Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lynton Lasers Limited · 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) |
|---|---|---|---|---|---|
| K072048 | LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL L | Lynton Lasers Limited | 2007-11-16 | 114 | 0 |
| K063427 | LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM | Lynton Lasers Limited | 2007-07-25 | 254 | 0 |
| K062871 | LUMACARE LC-122M NON-COHERENT LIGHT SOURCE | Lynton Lasers Limited | 2006-11-14 | 50 | 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