Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lexington International, LLC · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
346 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180885 | HairMax Laser | Lexington International, LLC | 2018-06-20 | 77 | 0 |
| K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014-12-01 | 80 | 0 |
| K112524 | HAIRMAX LASERCOMB | Lexington International, LLC | 2011-09-26 | 26 | 0 |
| K111714 | HAIRMAX DUAL 12 | Lexington International, LLC | 2011-08-16 | 57 | 0 |
| K110233 | HAIRMAX LASERCOMB | Lexington International, LLC | 2011-05-27 | 121 | 0 |
| K103368 | HAIRMAX LASERCOMB | Lexington International, LLC | 2011-04-06 | 140 | 0 |
| K093499 | HAIRMAX LASERCOMB | Lexington International, LLC | 2009-11-23 | 11 | 0 |
| K060305 | HAIRMAX LASERCOMB | Lexington International, LLC | 2007-01-18 | 346 | 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