Alma Lasers, Inc.: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Alma Lasers, Inc.” (first 2007, latest 2026), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 132 days. Since 2017 the median was 115 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 117 |
| 2013 | 0 | — |
| 2014 | 2 | 218 |
| 2015 | 0 | — |
| 2016 | 1 | 216 |
| 2017 | 3 | 85 |
| 2018 | 2 | 100 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 364 |
| 2022 | 2 | 234 |
| 2023 | 2 | 18 |
| 2024 | 1 | 139 |
| 2025 | 3 | 196 |
| 2026 | 1 | 368 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alma Lasers, Inc. took a median 115 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 22 | 22 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| NUV | Massager, Vacuum, Light Induced Heating | 2 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| MUU | System, Suction, Lipoplasty | 1 | 1 |
| OAP | Laser, Comb, Hair | 1 | 1 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 | 1 |
Review panels
Most recent Alma Lasers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251684 | Alma TED+ System | OAP | 2026-06-05 | 368 |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories | GEX | 2025-09-24 | 257 |
| K251230 | The Alma Hybrid Laser System | GEX | 2025-05-21 | 30 |
| K243044 | Alma Harmony | GEX | 2025-04-11 | 196 |
| K233024 | Alma Harmony | GEX | 2024-02-08 | 139 |
| K230308 | Alma Harmony | GEX | 2023-03-01 | 26 |
| K230371 | The Alma Soprano Titanium | GEX | 2023-02-22 | 9 |
| K222064 | The Alma Soprano Titanium | GEX | 2022-10-12 | 91 |
| K212073 | Alma Diode Tabletop Laser | GEX | 2022-07-14 | 377 |
| K201520 | The Alma Opus System, Colibri Applicator and Tips | GEI | 2021-10-27 | 506 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alma Lasers, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Alma Lasers, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04640207: The Efficacy of the Alma Hybrid System for a New Approach of Facial Skin Treatment (Completed, started 2020-11-25)
- NCT04599751: The Trio Laser Module for Hair Removal Treatment (Completed, started 2020-10-07)
- NCT03800563: Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System (Completed, started 2018-11-06)
- NCT04519736: Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage - A Split Face Comparison Study (Completed, started 2013-05)
- NCT04519723: Laser 360iQ: Optimal Light-laser Combination Therapy (Completed, started 2013-02)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alma, Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alma Lasers, Inc.?
FDA lists 34 510(k) clearances under the applicant name “Alma Lasers, Inc.” (first 2007, latest 2026), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alma Lasers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alma Lasers, Inc. is 132 days. Since 2017: 115 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Alma Lasers, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 22); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); NUV (Massager, Vacuum, Light Induced Heating, 2).
Next steps
- See all 34 Alma Lasers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Alma Lasers, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.