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FDA 510(k)

ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE

K-Number: K020657 · 2002-07-29

ApplicantAcculaser, Inc.
Decision Date2002-07-29
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Acculaser, Inc.. It received FDA 510(k) clearance on 2002-07-29 under 510(k) number K020657. 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 PRO LOW LEVEL LASER THERAPY DEVICE?

ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 2002-07-29. The listed applicant is Acculaser, Inc.. The 510(k) number is K020657.

When did ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE receive FDA 510(k) clearance?

ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE received FDA 510(k) clearance on 2002-07-29, under 510(k) number K020657.

Who is the listed applicant for ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE?

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 PRO LOW LEVEL LASER THERAPY DEVICE?

The FDA product code for ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K023060ACCULASER PRO4

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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