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FDA 510(k)

REVLIGHT SKIN CARE SYSTEM

K-Number: K042630 · 2005-06-27

ApplicantSkincare Technology, Inc.
Decision Date2005-06-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REVLIGHT SKIN CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Skincare Technology, Inc.. It received FDA 510(k) clearance on 2005-06-27 under 510(k) number K042630. 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 REVLIGHT SKIN CARE SYSTEM?

REVLIGHT SKIN CARE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-27. The listed applicant is Skincare Technology, Inc.. The 510(k) number is K042630.

When did REVLIGHT SKIN CARE SYSTEM receive FDA 510(k) clearance?

REVLIGHT SKIN CARE SYSTEM received FDA 510(k) clearance on 2005-06-27, under 510(k) number K042630.

Who is the listed applicant for REVLIGHT SKIN CARE SYSTEM?

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

What is the FDA product code for REVLIGHT SKIN CARE SYSTEM?

The FDA product code for REVLIGHT SKIN CARE SYSTEM 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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