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FDA 510(k)

MLS-AC DERMA SCANNER

K-Number: K101430 · 2010-06-22

ApplicantErchonia Corporation
Decision Date2010-06-22
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MLS-AC DERMA SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2010-06-22 under 510(k) number K101430. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MLS-AC DERMA SCANNER?

MLS-AC DERMA SCANNER is a medical device that received FDA 510(k) clearance on 2010-06-22. The listed applicant is Erchonia Corporation. The 510(k) number is K101430.

When did MLS-AC DERMA SCANNER receive FDA 510(k) clearance?

MLS-AC DERMA SCANNER received FDA 510(k) clearance on 2010-06-22, under 510(k) number K101430.

Who is the listed applicant for MLS-AC DERMA SCANNER?

The FDA 510(k) record lists Erchonia Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MLS-AC DERMA SCANNER?

The FDA product code for MLS-AC DERMA SCANNER is NHN.

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Other records listing Erchonia Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251903Erchonia DPN Laser (Model# EVRL)K252574Erchonia CLX (Model # CFL)K251843Erchonia EVRLK243811Erchonia Zerona® VZ8K231409Erchonia FX-405K231474Erchonia Violet ZERONA® Z6 OTC

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Related Devices (Code: NHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia CorporationK252273Therapy USDmc Importação E Exportação DE Equipamentos LtdaK241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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