Atlas FDA

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

Wavelight Laser Technologie AG · Predicate Candidate Screening

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

30 daysmedian FDA review time
90 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K053604WAVELIGHT IDASWavelight Laser Technologie AG2006-02-22570
K052806BURANEWavelight Laser Technologie AG2005-10-17130
K051399WAVELIGHT AURIGAWavelight Laser Technologie AG2005-06-30300
K050317BURANE XLWavelight Laser Technologie AG2005-02-24150
K050218WAVELIGHT SINONWavelight Laser Technologie AG2005-02-15150
K042474ARIONWavelight Laser Technologie AG2004-09-29160
K040433SINONWavelight Laser Technologie AG2004-05-19900
K040384MYDON CWavelight Laser Technologie AG2004-05-14870

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