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FDA 510(k)

RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY

K-Number: K051671 · 2005-09-02

ApplicantRadiancy (Israel) , Ltd.
Decision Date2005-09-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY 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 2005-09-02 under 510(k) number K051671. 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 SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY?

RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY is a medical device that received FDA 510(k) clearance on 2005-09-02. The listed applicant is Radiancy (Israel) , Ltd.. The 510(k) number is K051671.

When did RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY receive FDA 510(k) clearance?

RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY received FDA 510(k) clearance on 2005-09-02, under 510(k) number K051671.

Who is the listed applicant for RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY?

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 SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY?

The FDA product code for RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY 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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