Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Light Age, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
153 daysmedian FDA review time
355 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113115 | EPICARE YAG | Light Age, Inc. | 2012-04-03 | 165 | 0 |
| K110370 | Q-CLEAR | Light Age, Inc. | 2011-09-15 | 219 | 0 |
| K091625 | EPICARE-DUO LASER SYSTEM | Light Age, Inc. | 2009-11-03 | 153 | 0 |
| K032991 | LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, | Light Age, Inc. | 2004-09-14 | 355 | 0 |
| K033259 | LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 | Light Age, Inc. | 2004-02-25 | 139 | 0 |
| K983977 | LIGHT AGE EPICARE ALEXANDRITE LASER | Light Age, Inc. | 1999-01-07 | 59 | 0 |
| K980131 | ALEX TA2 ERASER | Light Age, Inc. | 1998-02-17 | 33 | 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