Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Foreo, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
290 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253683 | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | Foreo, Inc. | 2026-02-20 | 91 | 0 |
| K242747 | FAQ™ (302) | Foreo, Inc. | 2024-12-11 | 90 | 0 |
| K241102 | Luna 4 plus | Foreo, Inc. | 2024-08-20 | 120 | 0 |
| K240616 | FAQ™ (102) | Foreo, Inc. | 2024-07-15 | 132 | 0 |
| K232242 | BEAR 2 Body | Foreo, Inc. | 2024-05-13 | 290 | 0 |
| K240378 | FAQ™ 201, FAQ™ 202 | Foreo, Inc. | 2024-04-19 | 72 | 0 |
| K231977 | PEACH 2, PEACH 2 Duo, PEACH 2 go | Foreo, Inc. | 2023-09-25 | 84 | 0 |
| K222012 | FAQ 101 | Foreo, Inc. | 2023-04-05 | 271 | 0 |
| K200803 | BEAR and BEAR mini | Foreo, Inc. | 2020-07-31 | 126 | 0 |
| K162450 | ESPADA Acne-Clearing Blue Light Pen | Foreo, Inc. | 2016-11-30 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda