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FDA 510(k)

EPILATOR

K-Number: K952117 · 1995-10-19

ApplicantBurke Neutech, Inc.
Decision Date1995-10-19
Product CodeKCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Burke Neutech, Inc.. It received FDA 510(k) clearance on 1995-10-19 under 510(k) number K952117. 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?

EPILATOR is a medical device that received FDA 510(k) clearance on 1995-10-19. The listed applicant is Burke Neutech, Inc.. The 510(k) number is K952117.

When did EPILATOR receive FDA 510(k) clearance?

EPILATOR received FDA 510(k) clearance on 1995-10-19, under 510(k) number K952117.

Who is the listed applicant for EPILATOR?

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

What is the FDA product code for EPILATOR?

The FDA product code for EPILATOR is KCX.

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Other records listing Burke Neutech, Inc. 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.

K955326SPORTS CONTRAST THERAPY SYSTEM ST 7000K943497CONTRAST 7000 THERAPY SYSTEMK945803THERMAFLEX, MODEL SD 55 C.P.M.H.K942926NEURO-AIDEK940160TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEMK926151LSI6000 THERMAL THERAPY SYSTEM

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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