Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sharplight Technologies, Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233304 | Omnimax S3, Omnimax S4 | Sharplight Technologies, Ltd. | 2023-12-22 | 84 | 0 |
| K173169 | Rapid Family | Sharplight Technologies, Ltd. | 2017-11-20 | 52 | 0 |
| K111303 | DERMATOLOGICAL TREATMENT DEVICE FAMILY | Sharplight Technologies, Ltd. | 2011-12-21 | 226 | 0 |
| K082876 | BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY | Sharplight Technologies, Ltd. | 2008-11-10 | 42 | 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