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FDA 510(k)

COOLTOUCH, MODEL CTEV

K-Number: K061618 · 2006-09-25

ApplicantNew Star Lasers, Inc.
Decision Date2006-09-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOLTOUCH, MODEL CTEV 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 2006-09-25 under 510(k) number K061618. 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, MODEL CTEV?

COOLTOUCH, MODEL CTEV is a medical device that received FDA 510(k) clearance on 2006-09-25. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K061618.

When did COOLTOUCH, MODEL CTEV receive FDA 510(k) clearance?

COOLTOUCH, MODEL CTEV received FDA 510(k) clearance on 2006-09-25, under 510(k) number K061618.

Who is the listed applicant for COOLTOUCH, MODEL CTEV?

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, MODEL CTEV?

The FDA product code for COOLTOUCH, MODEL CTEV 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.

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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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