510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Erchonia Corporation

Fountain Inn, SC, US

ERCHONIA CORPORATION appears in FDA device records in Fountain Inn, SC. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
26
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 26 510(k) clearances for Erchonia Corporation between 2010 and 2026. The busiest year on record is 2016, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Erchonia Corporation, by decision year
YearClearances
20102
20122
20131
20142
20152
20163
20181
20192
20201
20212
20222
20232
20253
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251903Erchonia DPN Laser (Model# EVRL)NHNSubstantially Equivalent
K252574Erchonia CLX (Model # CFL)OLISubstantially Equivalent
K251843Erchonia EVRLOLPSubstantially Equivalent
K243811Erchonia Zerona® VZ8OLISubstantially Equivalent
K231409Erchonia FX-405NHNSubstantially Equivalent
K231474Erchonia Violet ZERONA® Z6 OTCOLISubstantially Equivalent
K221987Erchonia GVLNHNSubstantially Equivalent
K220519Erchonia Zerona Z-BedOLISubstantially Equivalent
K212595Erchonia FX-405NHNSubstantially Equivalent
K211186Erchonia XLR8NHNSubstantially Equivalent
K192544Erchonia EmeraldOLISubstantially Equivalent
K191257Erchonia EVRLNHNSubstantially Equivalent
K190572Erchonia FX-635NHNSubstantially Equivalent
K180197Erchonia FX-635NHNSubstantially Equivalent
K162578Zerona Z6 OTCOLISubstantially Equivalent
K152196Erchonia EVRLNHNSubstantially Equivalent
K153052Erchonia PL TouchNHNSubstantially Equivalent
K150446Erchonia Zerona 6 headed scanner EZ6OLISubstantially Equivalent
K143007Erchonia Zerona Z6 OTCOLISubstantially Equivalent
K142042ERCHONIA SHLOLISubstantially Equivalent
K133718ZERONAOLISubstantially Equivalent
K123237ZERONA 2.0 LASEROLISubstantially Equivalent
K121695ERCHONIA ZERONAOLISubstantially Equivalent
K121690ETCHONIA ZERONA ARMSOLISubstantially Equivalent
K101430MLS-AC DERMA SCANNERNHNSubstantially Equivalent
K100509THL1 LASERNHNSubstantially Equivalent

Registered establishments

FDA registered establishments for Erchonia Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20325133003462036ERCHONIA CORPORATION112 Southchase Blvd, Fountain Inn, SC 29644 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain