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

Erchonia Medical, Inc. · Predicate Candidate Screening

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

159 daysmedian FDA review time
260 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K153164LunulaLaserErchonia Medical, Inc.2016-06-032140
K132940ERCHONIA ALLAYErchonia Medical, Inc.2014-04-142070
K130996ERCHONIA EMERGEErchonia Medical, Inc.2013-09-161590
K130922ERCHONIA VERJU LASER SYSTEM WITH MASSAGERErchonia Medical, Inc.2013-05-17440
K130741ERCHONIA PL5000Erchonia Medical, Inc.2013-04-23350
K120257MLS, ZERONA-ADErchonia Medical, Inc.2012-05-141080
K072206ERCHONIA EML LASERErchonia Medical, Inc.2008-04-242600
K062792ERCHONIA IOTO_240Erchonia Medical, Inc.2007-03-011640
K050672ERCHONIA EVRL LASERErchonia Medical, Inc.2005-05-02480
K041139ERCHONIA EML LASERErchonia Medical, Inc.2004-09-301530

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