Clearance Summary
810nm Diode Laser System received FDA 510(k) clearance under submission number K183122, sponsored by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-08-25.
- Submission: K183122
- Applicant / Sponsor: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2019-08-25
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.