Foreo Inc
Las Vegas, NV, US
FOREO INC appears in FDA device records in Las Vegas, NV. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Foreo Inc between 2016 and 2026. The busiest year on record is 2024, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2020 | 1 |
| 2023 | 2 |
| 2024 | 5 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253683 | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | OHS | Substantially Equivalent | |
| K242747 | FAQ™ (302) | OAP | Substantially Equivalent | |
| K241102 | Luna 4 plus | OHS | Substantially Equivalent | |
| K240616 | FAQ™ (102) | PAY | Substantially Equivalent | |
| K232242 | BEAR 2 Body | NFO | Substantially Equivalent | |
| K240378 | FAQ™ 201, FAQ™ 202 | OHS | Substantially Equivalent | |
| K231977 | PEACH 2, PEACH 2 Duo, PEACH 2 go | OHT | Substantially Equivalent | |
| K222012 | FAQ 101 | PAY | Substantially Equivalent | |
| K200803 | BEAR and BEAR mini | NFO | Substantially Equivalent | |
| K162450 | ESPADA Acne-Clearing Blue Light Pen | OLP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012104022 | 3012104022 | FOREO INC | 1525 E Pama Lane, Las Vegas, NV 89119 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GFEBrush, Dermabrasion, Powered
- EEGHeat Source For Bleaching Teeth
- OAPLaser, Comb, Hair
- OHSLight Based Over The Counter Wrinkle Reduction
- OHTLight Based Over-The-Counter Hair Removal
- OLPOver-The-Counter Powered Light Based Laser For Acne
- PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- GEXPowered Laser Surgical Instrument
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
- JEQToothbrush, Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain