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FDA 510(k)

COOLTOUCH VARIA-II ND:YAG LASER SYSTEM

K-Number: K003781 · 2000-12-20

ApplicantCooltouch Corp.
Decision Date2000-12-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOLTOUCH VARIA-II ND:YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cooltouch Corp.. It received FDA 510(k) clearance on 2000-12-20 under 510(k) number K003781. 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 VARIA-II ND:YAG LASER SYSTEM?

COOLTOUCH VARIA-II ND:YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2000-12-20. The listed applicant is Cooltouch Corp.. The 510(k) number is K003781.

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

COOLTOUCH VARIA-II ND:YAG LASER SYSTEM received FDA 510(k) clearance on 2000-12-20, under 510(k) number K003781.

Who is the listed applicant for COOLTOUCH VARIA-II ND:YAG LASER SYSTEM?

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 VARIA-II ND:YAG LASER SYSTEM?

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

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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.

K014035COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMSK010316COOLTOUCH 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 II

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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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