Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Photo Therapeutics Limited · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

106 daysmedian FDA review time
190 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K050216OMNILUX REVIVE AND OMNILUX PLUSPhoto Therapeutics Limited2005-08-091900
K043329OMNILUX REVIVE AND BLUEPhoto Therapeutics Limited2005-03-181060
K043317OMNILUX PLUSPhoto Therapeutics Limited2005-03-151030
K030426OMNILUX REDPhoto Therapeutics Limited2003-07-171570
K030883OMNILUX BLUEPhoto Therapeutics Limited2003-06-18900

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