Atlas FDA

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

A.R.C Laser GmbH · Predicate Candidate Screening

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

189 daysmedian FDA review time
247 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K220531FOX 810, FOX 980A.R.C Laser GmbH2022-09-011890
K192272Wolf445nmA.R.C Laser GmbH2020-03-172080
K170183Cetus system, Cetus probeA.R.C Laser GmbH2017-09-272470
K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH2016-08-16880
K091059FOXQ 980 LASERA.R.C Laser GmbH2009-08-131210
K073322FOX 1-980, FOX Q-1064, FOX-Q-810A.R.C Laser GmbH2008-02-22880

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