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Every weight-loss device the FDA has authorized, from the Lap-Band to swallowable balloons and gel capsules: exact indications, trial results and which are still sold. Checked October 7, 2026.
Fact-checked against FDA labels and official sources; not yet reviewed by a licensed clinician. This page is education, not medical advice. Talk to your doctor before starting, stopping or changing any treatment.
Key takeaways
- The FDA has authorized about a dozen weight-loss and weight-management devices since 2001; its own list (March 2026) names eight.[1]
- The newest is the swallowable Allurion balloon, approved Feb 20, 2026, for short-term limited weight loss in adults 22 to 65 with a BMI of 30 to 40.[9]
- Swallowed capsules (Plenity, Epitomee) produced about 2 points more weight loss than a placebo capsule over 24 weeks.[2]
- Several authorized devices, including AspireAssist and Plenity, are no longer sold, so authorization does not mean availability.[23]
- Every device is authorized for use with a diet, behavior or lifestyle program, never on its own.[1]
In short: The FDA has authorized about a dozen devices for weight loss or weight management since 2001, from a surgically placed band to balloons you swallow and capsules that swell with water in the stomach. In their pivotal trials, people using them lost on average roughly 2 to 9 percentage points more of their body weight than people in the comparison group, over 6 to 12 months. Several are no longer sold, so an FDA authorization does not mean you can get the device today. Checked on October 7, 2026.
This page lists every weight-loss device we could find in the FDA’s databases, with the exact group of people each one is authorized for and whether it is still on the market. For the procedures themselves, see our guides to the gastric balloon, endoscopic sleeve gastroplasty and the Lap-Band, and our side-by-side look at every weight-loss procedure. It is general education, not a recommendation for any device; you and your clinician decide what fits.
Weight-loss devices at a glance
- 13weight-loss or weight-management devices we found with an FDA authorization, 2001 to 2026FDA PMA, De Novo and 510(k) databases
- 8devices on the FDA's own weight-loss device page (current as of March 12, 2026)FDA
- Feb 20, 2026newest approval: the swallowable Allurion balloon (PMA P250023)FDA PMA database
- 3authorized devices confirmed off the market (Plenity, Obalon, AspireAssist); 3 more we could not find on sale
Checked on October 7, 2026
“Approved”, “cleared” and “granted”: what the FDA words mean
Devices reach the market by different routes, and the words differ for each. Higher-risk devices, such as balloons that stay in the stomach for months or a band placed in surgery, need premarket approval (PMA), the strictest route, which requires clinical evidence of safety and effectiveness. A new kind of lower-risk device with no earlier example can be granted a De Novo classification, which also sets “special controls” for later devices of the same type. Once a De Novo exists, a similar device can be cleared through a 510(k) by showing it is substantially equivalent to that earlier device. All three are FDA authorizations; none of them is a promise that a device will work for you.
The FDA’s consumer page splits these products into weight-loss devices (the band, the balloons and the endoscopic suturing device) and weight-management devices (a removable mouthpiece and a swallowed capsule). Its list, last updated on March 12, 2026, names eight products. It does not yet include the Allurion balloon or the Epitomee capsule, both authorized in the database, and it no longer includes several devices that were approved and later left the market.
Every device we found, with its exact indication
The table follows the order in which each device works in the body, from the mouth down, not any ranking. “Status” is what we could confirm on October 7, 2026, from company and government sources. All of them are for adults and all are used alongside a diet and activity program; none is a stand-alone fix.
| Device | Type | FDA route and date | Authorized for (as written by the FDA) | Status, October 2026 |
|---|---|---|---|---|
| SMART device (Scientific Intake) | Removable mouthpiece worn at meals | De Novo DEN150033, Sept 26, 2016; similar SmartByte cleared 2017 (K171165) | Overweight to obese adults, BMI 27-35, with behavioral modification instruction; prescription | We could not confirm that it is sold |
| Plenity (Gelesis) | Swallowed capsule; gel takes up space | De Novo DEN180060, Apr 12, 2019; over-the-counter version cleared Jan 19, 2024 (K230133) | Adults with BMI 25-40, with diet and exercise | Maker filed for Chapter 7 liquidation on Oct 30, 2023; we found no current US seller |
| Epitomee (Epitomee Medical) | Swallowed capsule; gel takes up space | 510(k) K240544, Sept 13, 2024 | Adults with BMI 25-40, with diet and exercise; prescription | Pre-launch program with selected US clinics |
| ORBERA (Boston Scientific) | Saline balloon placed by endoscope | PMA P140008, Aug 5, 2015 | Adults with BMI 30-40 who have not succeeded with diet, exercise and behavior programs; up to 6 months | Sold in the US |
| Spatz3 (Spatz) | Adjustable saline balloon placed by endoscope | PMA P190012, Oct 15, 2021 | Adults with BMI 35-40, or 30-34.9 with a major obesity-related condition, after a supervised weight program; up to 8 months | Maker lists clinics; US availability not confirmed by us |
| Allurion Gastric Balloon System | Swallowed balloon, no endoscopy; empties and passes on its own | PMA P250023, Feb 20, 2026 | Adults 22-65 with BMI 30-40 and at least one unsuccessful weight-loss program; up to two balloons over 10 months; “short-term limited weight loss” | First US commercial patients treated in April 2026 |
| Obalon Balloon System | Swallowed gas-filled balloons, removed by endoscope | PMA P160001, Sept 8, 2016 | Adults with BMI 30-40 who have not lost weight with diet and exercise; removed at 6 months | Not on sale; ReShape reported no Obalon revenue in 2025 and licensed it out |
| TransPyloric Shuttle (BAROnova) | Device that sits at the stomach outlet and slows emptying | PMA P180024, Apr 16, 2019 | Adults with BMI 35-40, or 30-34.9 with an obesity-related condition | We found no evidence it is sold |
| Apollo ESG and Revise systems | Endoscopic suturing to make the stomach smaller | De Novo DEN210045, July 12, 2022 | Adults with BMI 30-50 who have not lost weight, or kept it off, with more conservative measures (see our ESG guide) | In use in the US |
| Lap-Band | Adjustable band placed in surgery | PMA P000008, June 5, 2001; widened in 2011 to BMI 30-34 with a related condition | Originally BMI 40+, or 35+ with a severe related condition | Sold in the US; approval now held by Medtimo |
| Maestro (vBloc) system | Implanted nerve-blocking stimulator | PMA P130019, Jan 14, 2015 | Adults with BMI 40-45, or 35-39.9 with a related condition, after a supervised program | We found no evidence it is sold |
| AspireAssist | Stomach tube to drain part of a meal | PMA P150024, June 14, 2016 | Adults 22+ with BMI 35-55 who failed non-surgical therapy | Withdrawn from the market April 8, 2022 |
| Item | Low | High |
|---|---|---|
| SMART mouthpiece | 27 BMI | 35 BMI |
| Plenity and Epitomee capsules | 25 BMI | 40 BMI |
| ORBERA, Obalon, Allurion balloons | 30 BMI | 40 BMI |
| Spatz3 balloon, TransPyloric Shuttle | 30 BMI | 40 BMI |
| Apollo ESG | 30 BMI | 50 BMI |
| Maestro (vBloc) | 35 BMI | 45 BMI |
| AspireAssist | 35 BMI | 55 BMI |
Some devices require an obesity-related condition at the lower end of the range (Spatz3, TransPyloric Shuttle, Maestro). The Lap-Band has no upper limit and is left out. Use the BMI calculator to see your own number.
Source: FDA PMA, De Novo and 510(k) records (checked on October 7, 2026)
If you are not sure where you fall, our BMI calculator gives your number in a few seconds. A BMI inside a range does not make a device right for you: each label also lists conditions that rule it out, such as past stomach surgery, a large hiatal hernia, pregnancy or certain bowel problems.
Swallowed capsules: Plenity and Epitomee
These are the least invasive devices. You swallow a capsule with water before lunch and dinner; inside the stomach, it releases particles or a gel that soak up water and take up space, then pass through and leave the body. Plenity’s hydrogel, made from cellulose and citric acid, can absorb up to 100 times its own weight in water, according to its FDA summary.
The FDA’s own review is candid about how much they do. In Plenity’s 24-week GLOW trial of 436 adults, people lost 6.4% of their body weight on average, compared with 4.4% on a look-alike capsule filled with cane sugar. The trial missed its own goal of a 3-point difference, and the FDA wrote that the effectiveness was “not appropriate for an indication of weight loss”, which is why both capsules are authorized for weight management. People in the US sites saw a smaller difference than people in Europe. In Epitomee’s 24-week RESET trial of 279 adults at nine US sites, average loss was 6.6% vs 4.6% on placebo, and 55.5% lost at least 5%. Neither trial reported serious device-related side effects. With Plenity, the complaints that did occur were mostly digestive, such as bloating, constipation or infrequent bowel movements; in RESET, digestive side effects were no more common than with placebo.
Plenity’s story shows why “authorized” and “available” are different things. It was sold by prescription from 2020, and the FDA cleared an over-the-counter version in January 2024, but its maker, Gelesis, had filed for liquidation in October 2023 and its consumer website no longer loads. Epitomee says it is a prescription device and is running a pre-launch program with selected US clinics.
Gastric balloons: four approved, two still clearly sold
Balloons take up room in the stomach so you feel full sooner. ORBERA and Spatz3 are filled with saline after a doctor places them through the mouth with an endoscope under sedation, and are removed the same way. Obalon used swallowed capsules filled with gas, removed by endoscope at six months. The newest, the Allurion balloon, is swallowed as a capsule attached to a thin tube, filled with fluid in a roughly 15-minute office visit, and opens a valve on its own so it empties and passes naturally; in its trial it stayed in the stomach for 15.3 weeks on average.
In the Allurion approval trial, AUDACITY, 550 adults were randomized; those in the balloon group received up to two balloons over 10 months, and everyone had a moderate-intensity lifestyle program. At 48 weeks, weight loss averaged 6.87% vs 3.09% in the lifestyle-only group, and 58.0% of balloon users lost at least 5%. That difference missed the trial’s own 3-point “super-superiority” target under the main analysis, and the FDA approved it for “short-term limited weight loss”. Device-related serious adverse events affected 8 people (3.0%), all after the second balloon; one person had a stomach perforation that the investigators linked to an underlying clotting problem. There were no deaths and no small-bowel obstructions. Our gastric balloon guide has the full ORBERA and Spatz3 trial results and the FDA’s warnings about over-inflation, pancreatitis and deaths with liquid-filled balloons.
| Item | Device | Comparison group |
|---|---|---|
| Plenity capsule, 24 wk | 6.4% | 4.4% |
| Epitomee capsule, 24 wk | 6.6% | 4.6% |
| Obalon balloon, 24 wk | 6.6% | 3.4% |
| Allurion balloon, 48 wk | 6.9% | 3.1% |
| ORBERA balloon, 6 mo | 10.2% | 3.3% |
| TransPyloric Shuttle, 12 mo | 9.5% | 2.8% |
| AspireAssist, 52 wk | 12.1% | 3.6% |
| Spatz3 balloon, 32 wk | 15% | 3.3% |
Percent of starting body weight. Different trials, people, comparison groups and lengths: not a ranking and not head-to-head. Capsule trials used a placebo or sham capsule; most balloon trials compared with a lifestyle program alone.
Source: FDA De Novo decision summaries and Summaries of Safety and Effectiveness Data (DEN180060, K240544, P160001, P250023, P140008, P180024, P150024, P190012) (checked on October 7, 2026)
Two things stand out. First, the comparison group lost weight too, because everyone had diet and activity support, so the useful number is the gap between the bars, not the device bar alone. Second, the devices that stay longer or change the stomach more tend to show bigger gaps, and they also carry more procedure risk. For scale, people in the main trials of today’s leading weight-loss medicines lost about 15% to 21% on average over 68 to 72 weeks, as our comparison of FDA-approved medications shows; that is also a different set of trials.
The TransPyloric Shuttle and endoscopic sleeve gastroplasty
The TransPyloric Shuttle was a two-bulb silicone device placed by endoscope that sat at the outlet of the stomach and slowed how fast food left it. In its 12-month trial of 270 randomized adults, weight loss averaged 9.5% vs 2.8% in a supervised diet-and-exercise group, and 66.8% lost at least 5%. It is still on the FDA’s device page, but we found no evidence that it is sold today.
Endoscopic sleeve gastroplasty (ESG) uses the Apollo suturing system, passed through the mouth, to stitch the stomach into a narrower tube without incisions. The FDA granted it De Novo authorization in July 2022 for adults with a BMI of 30 to 50, and the same decision covers the Revise system used to tighten the connection after an earlier bypass. In the randomized MERIT trial, total weight loss at one year was 13.6% with ESG vs 0.8% with lifestyle changes alone. It is the most common endoscopic weight procedure in the US, with 4,587 cases in 2023 by the ASMBS estimate, compared with 1,461 balloon placements. Our ESG guide covers who it suits and what recovery is like.
Surgical and implanted devices: the band, vBloc and AspireAssist
The Lap-Band was the first FDA-approved weight-loss device, in June 2001, and in 2011 the FDA widened it to adults with a BMI of 30 to 34 and an obesity-related condition. It is still sold; the FDA database now lists Medtimo, Inc. as the holder of the approval. Its use has fallen sharply as the sleeve and bypass took over: the ASMBS counted 773 band operations in the US in 2023, down from 55,932 in 2011. Our Lap-Band guide and history of bariatric surgery explain why.
The Maestro system, also sold as vBloc, is an implanted device that sends electrical pulses to block signals in the vagus nerve between the brain and stomach. In its pivotal trial it was measured by excess weight loss, a different scale from the other devices: 24.4% of excess weight at 12 months vs 15.9% with a sham device. We found no current maker filing that mentions it, and no evidence that it is sold.
AspireAssist used a tube placed through the abdominal wall into the stomach, so that about 20 to 30 minutes after a meal a person could drain about 30% of the food eaten. In its one-year trial, people lost 12.1% of their body weight vs 3.6% with lifestyle therapy alone. Its maker withdrew it from the market on April 8, 2022, for financial reasons, and said the decision was not related to safety or effectiveness.
Our history of weight-loss hoaxes shows how old some of those products really are, and our guide to body contouring explains what fat-reduction devices can and cannot do.
What every device has in common
Every indication on this page includes a diet, behavior or lifestyle program, and the FDA repeats in its consumer advice that devices alone are not the solution. Results are averages: some people lose much more and some lose little. Most of these devices are temporary, and the balloon summaries show that people tend to regain part of the weight after removal unless the new habits hold; our guide to keeping weight off covers what helps. Medicare does not cover gastric balloons under its national policy, and private coverage for devices varies, so ask about cost before you start; our insurance guide explains how to check.
If you are thinking about a device
- Check the authorizationSearch the exact device name in the FDA database and read who it is indicated for.
- Check it is still soldAsk the clinic which device they use and since when; several approved devices are no longer made.
- Compare the optionsMedicines, surgery and devices differ a lot in results, risks and cost. Our procedures comparison helps.
- Ask about side effectsNausea, vomiting and pain are common early on with balloons; ask what support the clinic gives.
- Plan for afterwardAsk what the program includes once the device is removed or passes.
If you would like to see all your options side by side, including medicines and surgery, start with Find My Options or our hub on weight-loss procedures. To find a specialist, see our guide to finding a bariatric surgeon, many of whom also offer endoscopic treatments.
Records in this article
Related guides
Every Weight-Loss Procedure Compared: Surgery, Endoscopic and BalloonEvery weight-loss procedure compared: gastric sleeve, bypass, duodenal switch, SADI-S, band, endoscopic sleeve gastroplasty and gastric…
Medical Weight-Loss Procedures: surgical, endoscopic and devicesMedical weight-loss procedures compared: sleeve, bypass, duodenal switch, band, revision, endoscopic sleeve gastroplasty and gastric balloons…
Find a Bariatric Surgeon: credentials, accredited centers and what to askHow to find a qualified bariatric surgeon: board certification, MBSAQIP accredited centers, the evaluation steps, risks,…
Find an Obesity Medicine Doctor: credentials, verification and what to askHow to find an obesity medicine doctor: what ABOM certification means, how to verify it for…Questions to ask a professional
- Which device would you use for me, and is it still being made and supported?
- How does the expected weight loss compare with medicines or surgery for someone like me?
- What side effects are common in the first weeks, and how will you help me manage them?
- What does the program include after the device is removed or passes?
- What is the total cost, including follow-up visits?
Frequently asked questions
What weight-loss devices are FDA approved?
As of October 7, 2026, FDA-authorized devices include the Lap-Band, the ORBERA, Spatz3, Obalon and Allurion gastric balloons, the TransPyloric Shuttle, the Apollo ESG suturing system, the Maestro (vBloc) system, AspireAssist, the SMART mouthpiece and the Plenity and Epitomee capsules. Several are no longer sold.
Is there an FDA-approved weight-loss pill that is a device?
Two swallowed capsules are authorized as devices for weight management: Plenity (2019) and Epitomee (2024), for adults with a BMI of 25 to 40 alongside diet and exercise. In their trials they added about 2 points of weight loss over a placebo capsule at 24 weeks. Plenity is not currently sold as far as we could find; Epitomee is in a US pre-launch program.
Is the swallowable gastric balloon available in the US?
Yes. The FDA approved the Allurion Gastric Balloon System on February 20, 2026, and the company reported treating its first US commercial patients in April 2026. It is for adults 22 to 65 with a BMI of 30 to 40 who have tried a weight-loss program.
Does FDA approval mean a device works for everyone?
No. Authorization means the FDA found the benefits outweigh the risks for the group studied. Trial results are averages, and some people lose little. Every device is meant to be used with a diet and lifestyle program.
Does insurance cover weight-loss devices?
Coverage varies. Medicare does not cover gastric balloons under its national policy, and many private plans do not either. Ask the clinic and your insurer for the full cost, including follow-up visits and removal, before you decide.
References
- Weight-Loss and Weight-Management Devices (content current as of 2026-03-12). U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
- De Novo classification request for Plenity (DEN180060). U.S. Food and Drug Administration, 2019. (accessed October 7, 2026) Government page
- 510(k) K230133: Plenity (over-the-counter), cleared 2024-01-19. U.S. Food and Drug Administration, 2024. (accessed October 7, 2026) Government page
- Gelesis Holdings, Inc. Form 8-K: voluntary petition under Chapter 7 (October 30, 2023). U.S. Securities and Exchange Commission (EDGAR), 2023. (accessed October 7, 2026) Government page
- 510(k) K240544: Epitomee, cleared 2024-09-13 (indications and RESET trial summary). U.S. Food and Drug Administration, 2024. (accessed October 7, 2026) Government page
- Get Epitomee (prescription device; US pre-launch program). Epitomee Medical. (accessed October 7, 2026) Other
- De Novo classification request for the SMART Device (DEN150033): decision summary. U.S. Food and Drug Administration, 2016. (accessed October 7, 2026) Government page
- Summary of Safety and Effectiveness Data: Allurion Gastric Balloon System (P250023), AUDACITY trial. U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page
- PMA P250023: Allurion Gastric Balloon System (approved 2026-02-20). U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page
- Allurion treats first commercial patients in the United States (company-reported). Allurion Technologies (press release), 2026. (accessed October 7, 2026) News (reported facts only)
- PMA P140008: ORBERA Intragastric Balloon (approval order). U.S. Food and Drug Administration, 2015. (accessed October 7, 2026) Government page
- Orbera Intragastric Balloon System (US product page). Boston Scientific. (accessed October 7, 2026) Other
- Summary of Safety and Effectiveness Data: Spatz3 Adjustable Balloon System (P190012). U.S. Food and Drug Administration, 2021. (accessed October 7, 2026) Drug label
- Summary of Safety and Effectiveness Data: Obalon Balloon System (P160001). U.S. Food and Drug Administration, 2016. (accessed October 7, 2026) Government page
- ReShape Lifesciences Form 10-Q, Q1 2025 (Lap-Band active; no Obalon revenue; Obalon licensed to Biorad). U.S. Securities and Exchange Commission, 2025. (accessed October 7, 2026) Other
- Summary of Safety and Effectiveness Data: TransPyloric Shuttle (P180024). U.S. Food and Drug Administration, 2019. (accessed October 7, 2026) Government page
- De Novo DEN210045: APOLLO ESG, ESG SX, REVISE and REVISE SX Systems. U.S. Food and Drug Administration, 2022. (accessed October 7, 2026) Government page
- Abu Dayyeh BK, et al.. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. The Lancet, 2022. doi:10.1016/S0140-6736(22)01280-6 · PMID 35908555 (accessed October 7, 2026) Randomized trial
- Estimate of Bariatric Surgery Numbers, 2011-2023. American Society for Metabolic and Bariatric Surgery. (accessed October 7, 2026) Society statement
- PMA P000008: LAP-BAND Adjustable Gastric Banding System (approval order and current applicant). U.S. Food and Drug Administration, 2001. (accessed October 7, 2026) Government page
- Summary of Safety and Effectiveness Data: Maestro Rechargeable System (P130019). U.S. Food and Drug Administration, 2015. (accessed October 7, 2026) Government page
- Summary of Safety and Effectiveness Data: AspireAssist (P150024). U.S. Food and Drug Administration, 2016. (accessed October 7, 2026) Government page
- Aspire Bariatrics company update (AspireAssist withdrawn from the market, April 8, 2022). Aspire Bariatrics. (accessed October 7, 2026) Other
- Medical Devices for Weight Loss and Weight Management: What to Know. U.S. Food and Drug Administration (Consumer Update), 2022. (accessed October 7, 2026) Government page
- National Coverage Determination 100.1: Bariatric Surgery. Centers for Medicare and Medicaid Services. (accessed October 7, 2026) Government page
Facts checked on October 7, 2026
Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.
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