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FDA 510(k)

DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)

K-Number: K992482 · 1999-12-27

ApplicantRadiancy, Ltd.
Decision Date1999-12-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Radiancy, Ltd.. It received FDA 510(k) clearance on 1999-12-27 under 510(k) number K992482. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)?

DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) is a medical device that received FDA 510(k) clearance on 1999-12-27. The listed applicant is Radiancy, Ltd.. The 510(k) number is K992482.

When did DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) receive FDA 510(k) clearance?

DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) received FDA 510(k) clearance on 1999-12-27, under 510(k) number K992482.

Who is the listed applicant for DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)?

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

What is the FDA product code for DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)?

The FDA product code for DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Radiancy, 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.

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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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