Data / Medical devices / United States / Foreo Inc
Foreo Inc: FDA-registered device maker in Las Vegas, NV, United States, 10 510(k) clearances
Foreo Inc is registered with the FDA (registration 3012104022) in Las Vegas, NV, United States. It lists 10 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012104022
- Address
- 1525 E Pama Lane, Las Vegas, NV, United States, 89119
- Owner or operator
- FOREO INC (10050498)
- Roles
- Complaint file establishment
- First device listed
- November 24, 2015
- Registered through
- 2027
- Brand names listed
- BEAR, BEAR 2 Body, BEAR MINI, Bear 2, Bear 2 eyes & lips, Bear 2 go, ESPADA 2, ESPADA 2 PLUS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Complaint file establishment | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Complaint file establishment | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Complaint file establishment | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Complaint file establishment | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Complaint file establishment | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Complaint file establishment | accessdata.fda.gov |
| Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | PAY | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Complaint file establishment | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | 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 |
|---|---|---|---|---|---|---|
| February 20, 2026 | K253683 | FAQ (LED Panel); FAQ (Dual LED Panel) | OHS | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
| December 11, 2024 | K242747 | FAQ (302) | OAP | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
| August 20, 2024 | K241102 | Luna 4 plus | OHS | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
| July 15, 2024 | K240616 | FAQ (102) | PAY | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
| May 13, 2024 | K232242 | BEAR 2 Body | NFO | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
| April 19, 2024 | K240378 | FAQ 201, FAQ 202 | OHS | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
| September 25, 2023 | K231977 | PEACH 2, PEACH 2 Duo, PEACH 2 go | OHT | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
| April 5, 2023 | K222012 | FAQ 101 | PAY | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
| July 31, 2020 | K200803 | BEAR and BEAR mini | NFO | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
| November 30, 2016 | K162450 | ESPADA Acne-Clearing Blue Light Pen | OLP | Substantially Equivalent | Foreo, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Powered
- All makers of Heat Source For Bleaching Teeth
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
Updated February 20, 2026. 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.