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FDA 510(k)

TWEEZER-TYPE EPILATOR

K-Number: K970338 · 1997-07-01

ApplicantIgia Direct, Inc.
Decision Date1997-07-01
Product CodeKCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TWEEZER-TYPE EPILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Igia Direct, Inc.. It received FDA 510(k) clearance on 1997-07-01 under 510(k) number K970338. 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 TWEEZER-TYPE EPILATOR?

TWEEZER-TYPE EPILATOR is a medical device that received FDA 510(k) clearance on 1997-07-01. The listed applicant is Igia Direct, Inc.. The 510(k) number is K970338.

When did TWEEZER-TYPE EPILATOR receive FDA 510(k) clearance?

TWEEZER-TYPE EPILATOR received FDA 510(k) clearance on 1997-07-01, under 510(k) number K970338.

Who is the listed applicant for TWEEZER-TYPE EPILATOR?

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

What is the FDA product code for TWEEZER-TYPE EPILATOR?

The FDA product code for TWEEZER-TYPE EPILATOR 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.K973174SONIQUE HAIR REMOVERGlobal TV Concepts, Ltd.K973179FEMINIQUE SONIC HAIR REMOVERGlobal TV Concepts, Ltd.K972695FINALLY FREEMehl/Group MarketingK935706EPI 2Universal H.R. System, 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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