Foreo, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Foreo, Inc.” (first 2016, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 106 days. Since 2017 the median was 120 days, against 89 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 |
|---|---|---|
| 2016 | 1 | 90 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 126 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 178 |
| 2024 | 5 | 120 |
| 2025 | 0 | — |
| 2026 | 1 | 91 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Foreo, Inc. took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | 3 | 3 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 2 | 2 |
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | 2 | 2 |
| OAP | Laser, Comb, Hair | 1 | 1 |
| OHT | Light Based Over-The-Counter Hair Removal | 1 | 1 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 1 | 1 |
Review panels
Most recent Foreo, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253683 | FAQ (LED Panel); FAQ (Dual LED Panel) | OHS | 2026-02-20 | 91 |
| K242747 | FAQ (302) | OAP | 2024-12-11 | 90 |
| K241102 | Luna 4 plus | OHS | 2024-08-20 | 120 |
| K240616 | FAQ (102) | PAY | 2024-07-15 | 132 |
| K232242 | BEAR 2 Body | NFO | 2024-05-13 | 290 |
| K240378 | FAQ 201, FAQ 202 | OHS | 2024-04-19 | 72 |
| K231977 | PEACH 2, PEACH 2 Duo, PEACH 2 go | OHT | 2023-09-25 | 84 |
| K222012 | FAQ 101 | PAY | 2023-04-05 | 271 |
| K200803 | BEAR and BEAR mini | NFO | 2020-07-31 | 126 |
| K162450 | ESPADA Acne-Clearing Blue Light Pen | OLP | 2016-11-30 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Foreo, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Foreo, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Foreo, Inc.” (first 2016, latest 2026), across 6 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 Foreo, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Foreo, Inc. is 106 days. Since 2017: 120 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Foreo, Inc.?
The most frequent FDA product codes under this applicant name are OHS (Light Based Over The Counter Wrinkle Reduction, 3); NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 2); PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction, 2).
Next steps
- See all 10 Foreo, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OHS, Foreo, 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.