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FDA 510(k)

CO2 Laser Therapy Systems

K-Number: K162398 · 2017-07-06

ApplicantBeijing Sincoheren Science and Technology Development Co.
Decision Date2017-07-06
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CO2 Laser Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sincoheren Science and Technology Development Co.. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K162398. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO2 Laser Therapy Systems?

CO2 Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Beijing Sincoheren Science and Technology Development Co.. The 510(k) number is K162398.

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

CO2 Laser Therapy Systems received FDA 510(k) clearance on 2017-07-06, under 510(k) number K162398.

Who is the listed applicant for CO2 Laser Therapy Systems?

The FDA 510(k) record lists Beijing Sincoheren Science and Technology Development Co. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for CO2 Laser Therapy Systems is ONG.

Other records listing Beijing Sincoheren Science and Technology Development Co. 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.

K163123Q-Switched Nd:YAG Laser Therapy Systems

Related Devices (Code: ONG)

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.

K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.K244060eCO2 3DLutronic CorporationK251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.K233550MOSAIC 3D (Surgical Laser)Lutronic AestheticK223871Miria Skin Treatment SystemAVAVA, Inc.

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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