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FDA 510(k)

DAPELLE HAIR REMOVER

K-Number: K973773 · 1997-12-17

ApplicantWellquest Intl., Inc.
Decision Date1997-12-17
Product CodeKCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DAPELLE HAIR REMOVER is the device name listed in this FDA 510(k) record. The listed applicant is Wellquest Intl., Inc.. It received FDA 510(k) clearance on 1997-12-17 under 510(k) number K973773. 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 DAPELLE HAIR REMOVER?

DAPELLE HAIR REMOVER is a medical device that received FDA 510(k) clearance on 1997-12-17. The listed applicant is Wellquest Intl., Inc.. The 510(k) number is K973773.

When did DAPELLE HAIR REMOVER receive FDA 510(k) clearance?

DAPELLE HAIR REMOVER received FDA 510(k) clearance on 1997-12-17, under 510(k) number K973773.

Who is the listed applicant for DAPELLE HAIR REMOVER?

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

What is the FDA product code for DAPELLE HAIR REMOVER?

The FDA product code for DAPELLE HAIR REMOVER 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.

K973340TWEEZER-TYPE EPILATORMobit, Inc.K973174SONIQUE HAIR REMOVERGlobal TV Concepts, Ltd.K973179FEMINIQUE SONIC HAIR REMOVERGlobal TV Concepts, Ltd.K972695FINALLY FREEMehl/Group MarketingK970338TWEEZER-TYPE EPILATORIgia Direct, Inc.K935706EPI 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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