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FDA 510(k)

RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT

K-Number: K051268 · 2005-07-06

ApplicantRadiancy, Ltd.
Decision Date2005-07-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Radiancy, Ltd.. It received FDA 510(k) clearance on 2005-07-06 under 510(k) number K051268. 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 RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT?

RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT is a medical device that received FDA 510(k) clearance on 2005-07-06. The listed applicant is Radiancy, Ltd.. The 510(k) number is K051268.

When did RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT receive FDA 510(k) clearance?

RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT received FDA 510(k) clearance on 2005-07-06, under 510(k) number K051268.

Who is the listed applicant for RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT?

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 RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT?

The FDA product code for RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT is GEX. This falls under the Gastroenterology category.

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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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