FDA 510(k)

COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS

K-Number: K031954 · 2003-08-21

Decision Date2003-08-21

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is New Star Lasers, Inc.. It received FDA 510(k) clearance on 2003-08-21 under 510(k) number K031954. 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 INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS?

COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 2003-08-21. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K031954.

When did COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS receive FDA 510(k) clearance?

COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS received FDA 510(k) clearance on 2003-08-21, under 510(k) number K031954.

Who is the listed applicant for COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS?

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

What is the FDA product code for COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS?

The FDA product code for COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS is GEX. This falls under the Gastroenterology category.

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Other records listing New Star Lasers, Inc. as applicant

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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.