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

Asclepion-Meditec AG — Predicate Candidate Screening

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

88 daysmedian FDA review time
177 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K021975LASERSYSTEM BEAUTYSTAR 532Asclepion-Meditec AG2002-09-13880
K014057DERMASTAR ER:YAG LASER SYSTEMAsclepion-Meditec AG2002-03-08880
K013940LASER SYSTEM YELLOWSTARAsclepion-Meditec AG2002-02-26890
K002031PHACOFRAGMENTATION SYSTEM MEGATRONAsclepion-Meditec AG2000-12-271770
K002032C02 LASER MULTIPULSEAsclepion-Meditec AG2000-09-11700

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