Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zap Lasers, LLC · 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) |
|---|---|---|---|---|---|
| K091796 | SOFTLASE PRO, ORTHOLASE AND HYGIENELASE | Zap Lasers, LLC | 2009-07-31 | 44 | 0 |
| K081214 | STYLA MICROLASER AND STYLAORTHO | Zap Lasers, LLC | 2008-05-14 | 14 | 0 |
| K021227 | SOFTLASE G2-SURGICAL DIODE LASER SYSTEM | Zap Lasers, LLC | 2002-06-26 | 69 | 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