Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Derma-Lase Co. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
184 daysmedian FDA review time
263 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932156 | MULTILINE; DLY-1 | Derma-Lase Co. | 1993-10-15 | 164 | 0 |
| K930793 | MULTILINE; DLY-1 | Derma-Lase Co. | 1993-08-19 | 184 | 0 |
| K930975 | DERMA-LASE DLA-1 LASER | Derma-Lase Co. | 1993-08-19 | 176 | 0 |
| K924647 | DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST | Derma-Lase Co. | 1993-06-04 | 263 | 0 |
| K913256 | DERMA-LASE RUBY LASER - MODEL DLR-1 | Derma-Lase Co. | 1992-01-22 | 190 | 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