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FDA 510(k)

AXIOM BIOLASER LLLT SERIES-1

K-Number: K030622 · 2003-09-09

ApplicantAxiom Usa., Inc.
Decision Date2003-09-09
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AXIOM BIOLASER LLLT SERIES-1 is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Usa., Inc.. It received FDA 510(k) clearance on 2003-09-09 under 510(k) number K030622. 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 AXIOM BIOLASER LLLT SERIES-1?

AXIOM BIOLASER LLLT SERIES-1 is a medical device that received FDA 510(k) clearance on 2003-09-09. The listed applicant is Axiom Usa., Inc.. The 510(k) number is K030622.

When did AXIOM BIOLASER LLLT SERIES-1 receive FDA 510(k) clearance?

AXIOM BIOLASER LLLT SERIES-1 received FDA 510(k) clearance on 2003-09-09, under 510(k) number K030622.

Who is the listed applicant for AXIOM BIOLASER LLLT SERIES-1?

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

What is the FDA product code for AXIOM BIOLASER LLLT SERIES-1?

The FDA product code for AXIOM BIOLASER LLLT SERIES-1 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 Axiom Usa., 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.

K033015AXIOM BIOLASER LLLT SERIES-3K022602DRX3000K023160DRX5000

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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