FDA 510(k)

ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS

K-Number: K022226 · 2002-10-08

Decision Date2002-10-08

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Altus Medical, Inc.. It received FDA 510(k) clearance on 2002-10-08 under 510(k) number K022226. 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 ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS?

ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS is a medical device that received FDA 510(k) clearance on 2002-10-08. The listed applicant is Altus Medical, Inc.. The 510(k) number is K022226.

When did ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS receive FDA 510(k) clearance?

ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS received FDA 510(k) clearance on 2002-10-08, under 510(k) number K022226.

Who is the listed applicant for ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS?

The FDA 510(k) record lists Altus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS?

The FDA product code for ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Altus Medical, Inc. as applicant

K033768ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE K023954ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES K014040FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS

Related Devices (Code: GEX)

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.