Company · US
Foreo, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 3 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 3 |
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | 2 |
| OAP | Laser, Comb, Hair | 1 |
| OHT | Light Based Over-The-Counter Hair Removal | 1 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2026 | K261565 | FAQ (FAQ 411) Foreo, Inc. | NFO |
| Feb 20, 2026 | K253683 | FAQ (LED Panel); FAQ (Dual LED Panel) Foreo, Inc. | OHS |
| Dec 11, 2024 | K242747 | FAQ (302) Foreo, Inc. | OAP |
| Aug 20, 2024 | K241102 | Luna 4 plus Foreo, Inc. | OHS |
| Jul 15, 2024 | K240616 | FAQ (102) Foreo, Inc. | PAY |
| May 13, 2024 | K232242 | BEAR 2 Body Foreo, Inc. | NFO |
| Apr 19, 2024 | K240378 | FAQ 201, FAQ 202 Foreo, Inc. | OHS |
| Sep 25, 2023 | K231977 | PEACH 2, PEACH 2 Duo, PEACH 2 go Foreo, Inc. | OHT |
| Apr 5, 2023 | K222012 | FAQ 101 Foreo, Inc. | PAY |
| Jul 31, 2020 | K200803 | BEAR and BEAR mini Foreo, Inc. | NFO |
| Nov 30, 2016 | K162450 | ESPADA Acne-Clearing Blue Light Pen Foreo, Inc. | OLP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||