Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Myriad Lase, Inc. · 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) |
|---|---|---|---|---|---|
| K965180 | STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000) | Myriad Lase, Inc. | 1997-06-05 | 163 | 0 |
| K952733 | SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS | Myriad Lase, Inc. | 1995-07-31 | 46 | 0 |
| K952113 | TBN-TIPPED OPTICAL FIBER | Myriad Lase, Inc. | 1995-06-01 | 27 | 0 |
| K920553 | MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER | Myriad Lase, Inc. | 1992-03-26 | 49 | 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