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FDA 510(k)

BODIHEALTH SYSTEM

K-Number: K052836 · 2007-02-13

ApplicantUsa Laser Therapeutics, Inc.
Decision Date2007-02-13
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BODIHEALTH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Usa Laser Therapeutics, Inc.. It received FDA 510(k) clearance on 2007-02-13 under 510(k) number K052836. 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 BODIHEALTH SYSTEM?

BODIHEALTH SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-13. The listed applicant is Usa Laser Therapeutics, Inc.. The 510(k) number is K052836.

When did BODIHEALTH SYSTEM receive FDA 510(k) clearance?

BODIHEALTH SYSTEM received FDA 510(k) clearance on 2007-02-13, under 510(k) number K052836.

Who is the listed applicant for BODIHEALTH SYSTEM?

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

What is the FDA product code for BODIHEALTH SYSTEM?

The FDA product code for BODIHEALTH SYSTEM is GZJ.

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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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