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FDA 510(k)

HAIR TRONICS MODEL HT8000

K-Number: K915845 · 1992-07-29

ApplicantGlobal Tronics Intl., Inc.
Decision Date1992-07-29
Product CodeKCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HAIR TRONICS MODEL HT8000 is the device name listed in this FDA 510(k) record. The listed applicant is Global Tronics Intl., Inc.. It received FDA 510(k) clearance on 1992-07-29 under 510(k) number K915845. The device is classified under product code KCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAIR TRONICS MODEL HT8000?

HAIR TRONICS MODEL HT8000 is a medical device that received FDA 510(k) clearance on 1992-07-29. The listed applicant is Global Tronics Intl., Inc.. The 510(k) number is K915845.

When did HAIR TRONICS MODEL HT8000 receive FDA 510(k) clearance?

HAIR TRONICS MODEL HT8000 received FDA 510(k) clearance on 1992-07-29, under 510(k) number K915845.

Who is the listed applicant for HAIR TRONICS MODEL HT8000?

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

What is the FDA product code for HAIR TRONICS MODEL HT8000?

The FDA product code for HAIR TRONICS MODEL HT8000 is KCX.

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Related Devices (Code: KCX)

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.

K973773DAPELLE HAIR REMOVERWellquest Intl., Inc.K973340TWEEZER-TYPE EPILATORMobit, Inc.K973179FEMINIQUE SONIC HAIR REMOVERGlobal TV Concepts, Ltd.K973174SONIQUE HAIR REMOVERGlobal TV Concepts, Ltd.K972695FINALLY FREEMehl/Group MarketingK970338TWEEZER-TYPE EPILATORIgia Direct, Inc.

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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