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FDA 510(k)

COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS

K-Number: K014035 · 2002-03-07

ApplicantCooltouch Corp.
Decision Date2002-03-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Cooltouch Corp.. It received FDA 510(k) clearance on 2002-03-07 under 510(k) number K014035. 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 AND COOLTOUCH-II ND:YAG LASER SYSTEMS?

COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 2002-03-07. The listed applicant is Cooltouch Corp.. The 510(k) number is K014035.

When did COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS receive FDA 510(k) clearance?

COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS received FDA 510(k) clearance on 2002-03-07, under 510(k) number K014035.

Who is the listed applicant for COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS?

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

What is the FDA product code for COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS?

The FDA product code for COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Cooltouch Corp. 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.

K010316COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEMK003715COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH IIK003781COOLTOUCH VARIA-II ND:YAG LASER SYSTEM

Related Devices (Code: GEX)

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.

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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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