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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 a medical device manufactured by Beijing Sincoheren Science and Technology Development Co.. It received FDA 510(k) clearance on 2017-07-06 under approval 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. It is manufactured by Beijing Sincoheren Science and Technology Development Co.. The 510(k) number is K162398.

When was CO2 Laser Therapy Systems approved by the FDA?

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

What company makes CO2 Laser Therapy Systems?

CO2 Laser Therapy Systems is manufactured by Beijing Sincoheren Science and Technology Development Co..

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

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

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Related PubMed Literature

PMID: 41483832 Emerging nanodelivery systems for cuproptosis induction: design strategies and multidimensional regulatory mechanisms. International journal of pharmaceutics (2026) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

Other Devices by Beijing Sincoheren Science and Technology Development Co.

K163123Q-Switched Nd:YAG Laser Therapy Systems

Related Devices (Code: ONG)

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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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