Clearance Summary
Medical Non-Ablative Fractional Laser Systems received FDA 510(k) clearance under submission number K192350, sponsored by Wingderm Electro-Optics , 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 2020-04-30.
- Submission: K192350
- Applicant / Sponsor: Wingderm Electro-Optics , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2020-04-30
Classification & Regulation
This clearance is catalogued under FDA product code ONG and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.