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FDA 510(k)

BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)

K-Number: K860056 · 1986-02-05

ApplicantBerkowits School of Electrolysis, Inc.
Decision Date1986-02-05
Product CodeKCW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Berkowits School of Electrolysis, Inc.. It received FDA 510(k) clearance on 1986-02-05 under 510(k) number K860056. The device is classified under product code KCW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)?

BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) is a medical device that received FDA 510(k) clearance on 1986-02-05. The listed applicant is Berkowits School of Electrolysis, Inc.. The 510(k) number is K860056.

When did BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) receive FDA 510(k) clearance?

BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) received FDA 510(k) clearance on 1986-02-05, under 510(k) number K860056.

Who is the listed applicant for BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)?

The FDA 510(k) record lists Berkowits School of Electrolysis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)?

The FDA product code for BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) is KCW.

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Related Devices (Code: KCW)

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.

K954031COMPU-BLEND EPILATORR. A. Fischer Co. Corp.K952611STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATIONSterex Electrolysis Intl., Ltd.K945192HAIR REMOVAL SYSTEML.P. Systems Corp.K943928APILUS ELECTROPILDectro Intl., Inc.K943398THE BLENDTONE ROYALEInstantronK943399THE SS-99Instantron

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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