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FDA 510(k)

COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY

K-Number: K090410 · 2009-03-27

ApplicantNew Star Lasers, Inc.
Decision Date2009-03-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY 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 2009-03-27 under 510(k) number K090410. 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 THERMAL SENSING HANDPIECE ACCESSORY?

COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY is a medical device that received FDA 510(k) clearance on 2009-03-27. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K090410.

When did COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY receive FDA 510(k) clearance?

COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY received FDA 510(k) clearance on 2009-03-27, under 510(k) number K090410.

Who is the listed applicant for COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY?

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 THERMAL SENSING HANDPIECE ACCESSORY?

The FDA product code for COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY is GEX. This falls under the Gastroenterology category.

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Other records listing New Star Lasers, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K103338COOLTOUCHK101783COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZEK092964COOLTOUCH VARIA ND:YAG LASER SYSTEMK081628MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPOK080163COOLTOUCH MODELS LC215 AND COOLLIPOK072751COOLTOUCH MODELS NS 160 AND LC215 COOLIPO

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Related Devices (Code: GEX)

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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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