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FDA 510(k)

RADIANCY FACIAL SKINCARE DEVICE

K-Number: K052991 · 2006-02-01

ApplicantRadiancy (Israel) , Ltd.
Decision Date2006-02-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RADIANCY FACIAL SKINCARE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Radiancy (Israel) , Ltd.. It received FDA 510(k) clearance on 2006-02-01 under 510(k) number K052991. 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 RADIANCY FACIAL SKINCARE DEVICE?

RADIANCY FACIAL SKINCARE DEVICE is a medical device that received FDA 510(k) clearance on 2006-02-01. The listed applicant is Radiancy (Israel) , Ltd.. The 510(k) number is K052991.

When did RADIANCY FACIAL SKINCARE DEVICE receive FDA 510(k) clearance?

RADIANCY FACIAL SKINCARE DEVICE received FDA 510(k) clearance on 2006-02-01, under 510(k) number K052991.

Who is the listed applicant for RADIANCY FACIAL SKINCARE DEVICE?

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

What is the FDA product code for RADIANCY FACIAL SKINCARE DEVICE?

The FDA product code for RADIANCY FACIAL SKINCARE DEVICE is GEX. This falls under the Gastroenterology category.

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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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