510(k) K162398
K162398 is an FDA 510(k) premarket notification submitted by Beijing Sincoheren Science and Technology Development Co. for the device "CO2 Laser Therapy Systems". The FDA issued a decision of Substantially Equivalent on July 6, 2017. The device falls under product code ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output), a Class II device regulated under 21 CFR 878.4810. Beijing Sincoheren Science and Technology Development Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2017
- Date Received
- August 26, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powered Laser Surgical Instrument With MicrobeamFractional Output
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
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.