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FDA 510(k)

LASER TOUCHONE

K-Number: K083822 · 2009-05-06

ApplicantLaser Health Technologies, LLC
Decision Date2009-05-06
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LASER TOUCHONE is the device name listed in this FDA 510(k) record. The listed applicant is Laser Health Technologies, LLC. It received FDA 510(k) clearance on 2009-05-06 under 510(k) number K083822. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER TOUCHONE?

LASER TOUCHONE is a medical device that received FDA 510(k) clearance on 2009-05-06. The listed applicant is Laser Health Technologies, LLC. The 510(k) number is K083822.

When did LASER TOUCHONE receive FDA 510(k) clearance?

LASER TOUCHONE received FDA 510(k) clearance on 2009-05-06, under 510(k) number K083822.

Who is the listed applicant for LASER TOUCHONE?

The FDA 510(k) record lists Laser Health Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASER TOUCHONE?

The FDA product code for LASER TOUCHONE is GZJ.

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 Laser Health Technologies, LLC 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.

K100116LASERTOUCHONE (OTC)

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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