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FDA 510(k)

SONIQUE HAIR REMOVER

K-Number: K973174 · 1997-10-30

ApplicantGlobal TV Concepts, Ltd.
Decision Date1997-10-30
Product CodeKCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SONIQUE HAIR REMOVER is the device name listed in this FDA 510(k) record. The listed applicant is Global TV Concepts, Ltd.. It received FDA 510(k) clearance on 1997-10-30 under 510(k) number K973174. 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 SONIQUE HAIR REMOVER?

SONIQUE HAIR REMOVER is a medical device that received FDA 510(k) clearance on 1997-10-30. The listed applicant is Global TV Concepts, Ltd.. The 510(k) number is K973174.

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

SONIQUE HAIR REMOVER received FDA 510(k) clearance on 1997-10-30, under 510(k) number K973174.

Who is the listed applicant for SONIQUE HAIR REMOVER?

The FDA 510(k) record lists Global TV Concepts, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONIQUE HAIR REMOVER?

The FDA product code for SONIQUE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Global TV Concepts, Ltd. 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.

K013707SOFTIQUE, MODEL GI 11001K973179FEMINIQUE SONIC HAIR REMOVER

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.K972695FINALLY FREEMehl/Group MarketingK970338TWEEZER-TYPE EPILATORIgia Direct, Inc.K935706EPI 2Universal H.R. System, 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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