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FDA 510(k)

COOLTOUCH V ND:YAG

K-Number: K983984 · 1999-06-07

ApplicantLaser Aesthetics, Inc.
Decision Date1999-06-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOLTOUCH V ND:YAG is the device name listed in this FDA 510(k) record. The listed applicant is Laser Aesthetics, Inc.. It received FDA 510(k) clearance on 1999-06-07 under 510(k) number K983984. 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 COOLTOUCH V ND:YAG?

COOLTOUCH V ND:YAG is a medical device that received FDA 510(k) clearance on 1999-06-07. The listed applicant is Laser Aesthetics, Inc.. The 510(k) number is K983984.

When did COOLTOUCH V ND:YAG receive FDA 510(k) clearance?

COOLTOUCH V ND:YAG received FDA 510(k) clearance on 1999-06-07, under 510(k) number K983984.

Who is the listed applicant for COOLTOUCH V ND:YAG?

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

What is the FDA product code for COOLTOUCH V ND:YAG?

The FDA product code for COOLTOUCH V ND:YAG 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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