Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gigaalaser Company , 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) |
|---|---|---|---|---|---|
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBO | Gigaalaser Company , Ltd. | 2025-05-19 | 249 | 0 |
| K250018 | Medical Diode Laser Systems (THEIA808) | Gigaalaser Company , Ltd. | 2025-04-01 | 88 | 0 |
| K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, G | Gigaalaser Company , Ltd. | 2025-03-19 | 271 | 0 |
| K230047 | Medical Diode Laser Systems | Gigaalaser Company , Ltd. | 2024-03-04 | 423 | 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