Data / Medical devices / United States / Alma Lasers, Inc.
Alma Lasers, Inc.: FDA-registered device maker in Buffalo Grove, IL, United States, 6 510(k) clearances
Alma Lasers, Inc. is registered with the FDA (registration 3004450661) in Buffalo Grove, IL, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004450661
- Address
- 485 Half Day Rd Ste 100, Buffalo Grove, IL, United States, 60089
- Owner or operator
- ALMA LASERS, INC. (9060821)
- Roles
- Complaint file establishment
- First device listed
- January 21, 2021
- Registered through
- 2026
- Brand names listed
- Alma DUO, Alma TED, Alma Veil, LMNT 02, LMNT One
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 6, 2025 | K251094 | Alma Veil | GEX | Substantially Equivalent | Wontech Co., Ltd. | accessdata.fda.gov |
| March 24, 2025 | K250125 | LMNT O2 | OHS | Substantially Equivalent | Xplr , Ltd. | accessdata.fda.gov |
| August 14, 2023 | K231054 | V-Laser | GEX | Substantially Equivalent | Wontech Co., Ltd. | accessdata.fda.gov |
| January 27, 2023 | K210166 | Omnispec ED1000 | ISA | Substantially Equivalent | Medispec, Ltd. | accessdata.fda.gov |
| August 24, 2022 | K221427 | V-Laser | GEX | Substantially Equivalent | Wontech Co., Ltd. | accessdata.fda.gov |
| July 26, 2018 | K181659 | Avologi ENEO | OHS | Substantially Equivalent | Premier North America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Massager, Therapeutic, Electric
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Light Based Over The Counter Wrinkle Reduction
Updated May 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.