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FDA 510(k)

EPILATOR 8500

K-Number: K851413 · 1985-06-10

ApplicantLois Yee Cosmetics, Inc.
Decision Date1985-06-10
Product CodeKCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPILATOR 8500 is the device name listed in this FDA 510(k) record. The listed applicant is Lois Yee Cosmetics, Inc.. It received FDA 510(k) clearance on 1985-06-10 under 510(k) number K851413. 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 EPILATOR 8500?

EPILATOR 8500 is a medical device that received FDA 510(k) clearance on 1985-06-10. The listed applicant is Lois Yee Cosmetics, Inc.. The 510(k) number is K851413.

When did EPILATOR 8500 receive FDA 510(k) clearance?

EPILATOR 8500 received FDA 510(k) clearance on 1985-06-10, under 510(k) number K851413.

Who is the listed applicant for EPILATOR 8500?

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

What is the FDA product code for EPILATOR 8500?

The FDA product code for EPILATOR 8500 is KCX.

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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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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