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FDA 510(k)

SKIN CARE LIGHT

K-Number: K070870 · 2007-10-10

ApplicantTransverse Industries Co.
Decision Date2007-10-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKIN CARE LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Transverse Industries Co.. It received FDA 510(k) clearance on 2007-10-10 under 510(k) number K070870. 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 SKIN CARE LIGHT?

SKIN CARE LIGHT is a medical device that received FDA 510(k) clearance on 2007-10-10. The listed applicant is Transverse Industries Co.. The 510(k) number is K070870.

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

SKIN CARE LIGHT received FDA 510(k) clearance on 2007-10-10, under 510(k) number K070870.

Who is the listed applicant for SKIN CARE LIGHT?

The FDA 510(k) record lists Transverse Industries Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKIN CARE LIGHT?

The FDA product code for SKIN CARE LIGHT 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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