FDA 510(k)

Fractional CO2 Surgical Laser System

K-Number: K173359 · 2018-07-05

Decision Date2018-07-05

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Fractional CO2 Surgical Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Ami, Inc.. It received FDA 510(k) clearance on 2018-07-05 under 510(k) number K173359. 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 Fractional CO2 Surgical Laser System?

Fractional CO2 Surgical Laser System is a medical device that received FDA 510(k) clearance on 2018-07-05. The listed applicant is Ami, Inc.. The 510(k) number is K173359.

When did Fractional CO2 Surgical Laser System receive FDA 510(k) clearance?

Fractional CO2 Surgical Laser System received FDA 510(k) clearance on 2018-07-05, under 510(k) number K173359.

Who is the listed applicant for Fractional CO2 Surgical Laser System?

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

What is the FDA product code for Fractional CO2 Surgical Laser System?

The FDA product code for Fractional CO2 Surgical Laser System 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.

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Other records listing Ami, Inc. as applicant

K233007Picosecond Nd:YAG Laser System; PICO LEGEND K172908Q-Switched Nd:YAG Laser System

Related Devices (Code: GEX)

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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.