Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Erchonia Corporation · Predicate Candidate Screening

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

88 daysmedian FDA review time

185 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days
K251903	Erchonia DPN Laser (Model# EVRL)	Erchonia Corporation	2026-02-19	244
K252574	Erchonia CLX (Model # CFL)	Erchonia Corporation	2025-12-15	123
K251843	Erchonia EVRL	Erchonia Corporation	2025-09-12	88
K243811	Erchonia Zerona® VZ8	Erchonia Corporation	2025-01-10	30
K231409	Erchonia FX-405	Erchonia Corporation	2023-08-11	88
K231474	Erchonia Violet ZERONA® Z6 OTC	Erchonia Corporation	2023-07-21	60
K221987	Erchonia GVL	Erchonia Corporation	2022-09-01	57
K220519	Erchonia Zerona Z-Bed	Erchonia Corporation	2022-03-24	29
K212595	Erchonia FX-405	Erchonia Corporation	2021-11-12	88
K211186	Erchonia XLR8	Erchonia Corporation	2021-10-22	185
K192544	Erchonia Emerald	Erchonia Corporation	2020-01-13	119
K191257	Erchonia EVRL	Erchonia Corporation	2019-08-08	90
K190572	Erchonia FX-635	Erchonia Corporation	2019-06-01	87
K180197	Erchonia FX-635	Erchonia Corporation	2018-05-21	117
K162578	Zerona Z6 OTC	Erchonia Corporation	2016-12-16	92
K152196	Erchonia EVRL	Erchonia Corporation	2016-02-18	197
K153052	Erchonia PL Touch	Erchonia Corporation	2016-01-04	76
K150446	Erchonia Zerona 6 headed scanner EZ6	Erchonia Corporation	2015-05-21	90
K143007	Erchonia Zerona Z6 OTC	Erchonia Corporation	2015-01-15	87
K142042	ERCHONIA SHL	Erchonia Corporation	2014-10-21	85
K133718	ZERONA	Erchonia Corporation	2014-05-12	159
K123237	ZERONA 2.0 LASER	Erchonia Corporation	2013-01-25	101
K121690	ETCHONIA ZERONA ARMS	Erchonia Corporation	2012-08-23	77
K121695	ERCHONIA ZERONA	Erchonia Corporation	2012-08-23	77
K101430	MLS-AC DERMA SCANNER	Erchonia Corporation	2010-06-22	32
K100509	THL1 LASER	Erchonia Corporation	2010-06-08	106

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