Cleared Traditional

K162398 - CO2 Laser Therapy Systems

K162398 is an FDA 510(k) clearance for CO2 Laser Therapy Systems, manufactured by Beijing Sincoheren Science and Technology Development Co.. The device is a Class 2 General & Plastic Surgery device with product code ONG cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K162398 · Beijing Sincoheren Science and Technology Development Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
314d
Days
Class 2
Risk

K162398 is an FDA 510(k) clearance for the CO2 Laser Therapy Systems. Classified as Powered Laser Surgical Instrument With Microbeamfractional Output (product code ONG), Class II - Special Controls.

Submitted by Beijing Sincoheren Science and Technology Development Co. (Beijing, CN). The FDA issued a Cleared decision on July 6, 2017 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Beijing Sincoheren Science and Technology Development Co. devices

FDA 510(k) Submission Details - K162398

510(k) Number K162398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2016
Decision Date July 06, 2017
Days to Decision 314 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 115d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ONG Device Classification - Class 2, Special Controls

Product Code ONG Powered Laser Surgical Instrument With Microbeamfractional Output
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. The Laser Output Is In Form Of Tiny Beams In Micro Range. Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic To Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue. Indication For Use Can Be General And/or Specific. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - ONG Powered Laser Surgical Instrument With Microbeamfractional Output

All 20
Devices cleared under the same product code (ONG) and FDA review panel - the closest regulatory comparables to K162398.
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K111840 · Palomar Medical Products, Inc. · Nov 2011
PRIMUS AESTHETIC PLATFORM
K103664 · Palomar Medical Technologies, Inc. · Mar 2011