Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laser Surgical Systems — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931445 | KTP/532, KTP/YAG AND KTP/YAG XP | Laser Surgical Systems | 1994-12-02 | 620 | 0 |
| K925266 | SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES | Laser Surgical Systems | 1993-04-15 | 178 | 0 |
| K922807 | FIBERLIFE | Laser Surgical Systems | 1992-12-15 | 188 | 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