Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO

K-Number: K081628 · 2008-06-20

ApplicantNew Star Lasers, Inc.
Decision Date2008-06-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO COOLTOUCH, MODELS LC225 AND 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 2008-06-20 under 510(k) number K081628. 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 MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO?

MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K081628.

When did MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO receive FDA 510(k) clearance?

MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO received FDA 510(k) clearance on 2008-06-20, under 510(k) number K081628.

Who is the listed applicant for MODIFICATION TO COOLTOUCH, MODELS LC225 AND 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 MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO?

The FDA product code for MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 ACCESSORYK080163COOLTOUCH MODELS LC215 AND COOLLIPOK072751COOLTOUCH MODELS NS 160 AND LC215 COOLIPO

View all 27 devices →

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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.

↑