Clearance Summary
Medical Diode Laser Systems received FDA 510(k) clearance under submission number K230047, sponsored by Gigaalaser Company , 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 2024-03-04.
- Submission: K230047
- Applicant / Sponsor: Gigaalaser Company , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2024-03-04
Classification & Regulation
This clearance is catalogued under FDA product code NVK and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.