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FDA 510(k)

CO2 Laser Therapy Machine

K-Number: K161925 · 2016-10-05

ApplicantBeijing Adss Development Co., Ltd.
Decision Date2016-10-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CO2 Laser Therapy Machine is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2016-10-05 under 510(k) number K161925. 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 CO2 Laser Therapy Machine?

CO2 Laser Therapy Machine is a medical device that received FDA 510(k) clearance on 2016-10-05. The listed applicant is Beijing Adss Development Co., Ltd.. The 510(k) number is K161925.

When did CO2 Laser Therapy Machine receive FDA 510(k) clearance?

CO2 Laser Therapy Machine received FDA 510(k) clearance on 2016-10-05, under 510(k) number K161925.

Who is the listed applicant for CO2 Laser Therapy Machine?

The FDA 510(k) record lists Beijing Adss Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser Therapy Machine?

The FDA product code for CO2 Laser Therapy Machine is GEX. This falls under the Gastroenterology category.

Other records listing Beijing Adss Development Co., Ltd. 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.

K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)K233307Intensity Pulsed Light Therapy SystemK231896Diode Laser Therapy SystemK231318Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)K220268Picosecond Laser System (Model PS10-A and PS10-B)K192295PDT-FACE

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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.

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 AmericaK261738Medical 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.

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