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FDA 510(k)

ACCULASER PRO4

K-Number: K023060 · 2004-03-19

ApplicantAcculaser, Inc.
Decision Date2004-03-19
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACCULASER PRO4 is the device name listed in this FDA 510(k) record. The listed applicant is Acculaser, Inc.. It received FDA 510(k) clearance on 2004-03-19 under 510(k) number K023060. 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 ACCULASER PRO4?

ACCULASER PRO4 is a medical device that received FDA 510(k) clearance on 2004-03-19. The listed applicant is Acculaser, Inc.. The 510(k) number is K023060.

When did ACCULASER PRO4 receive FDA 510(k) clearance?

ACCULASER PRO4 received FDA 510(k) clearance on 2004-03-19, under 510(k) number K023060.

Who is the listed applicant for ACCULASER PRO4?

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

What is the FDA product code for ACCULASER PRO4?

The FDA product code for ACCULASER PRO4 is NHN.

Related Clinical Trials

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.

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Other records listing Acculaser, Inc. 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.

K020657ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE

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

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

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