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FDA 510(k)

COOLTOUCH, MODEL LC215,COOLLIPO

K-Number: K072424 · 2007-10-03

ApplicantNew Star Lasers, Inc.
Decision Date2007-10-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOLTOUCH, MODEL LC215,COOLLIPO 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 2007-10-03 under 510(k) number K072424. 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 LC215,COOLLIPO?

COOLTOUCH, MODEL LC215,COOLLIPO is a medical device that received FDA 510(k) clearance on 2007-10-03. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K072424.

When did COOLTOUCH, MODEL LC215,COOLLIPO receive FDA 510(k) clearance?

COOLTOUCH, MODEL LC215,COOLLIPO received FDA 510(k) clearance on 2007-10-03, under 510(k) number K072424.

Who is the listed applicant for COOLTOUCH, MODEL LC215,COOLLIPO?

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 LC215,COOLLIPO?

The FDA product code for COOLTOUCH, MODEL LC215,COOLLIPO 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 SYSTEMK090410COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORYK081628MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPOK080163COOLTOUCH MODELS LC215 AND COOLLIPO

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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

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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