Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
G.N.S Neolaser , Ltd. · 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) |
|---|---|---|---|---|---|
| K250113 | neoLaser Laser Surgery Fibers | G.N.S Neolaser , Ltd. | 2025-03-13 | 56 | 0 |
| K152722 | neoV980 & neoV1470 Diode Lasers | G.N.S Neolaser , Ltd. | 2015-12-08 | 77 | 0 |
| K133006 | NEOV DIODE LASER FAMILY | G.N.S Neolaser , Ltd. | 2014-04-17 | 204 | 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