Clearance Summary
ReBorn (1050nm) received FDA 510(k) clearance under submission number K233962, sponsored by Lightfective , 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 2024-04-16.
- Submission: K233962
- Applicant / Sponsor: Lightfective , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5400
- Decision date: 2024-04-16
Classification & Regulation
This clearance is catalogued under FDA product code PKT and 21 CFR 878.5400, within the General, Plastic Surgery review panel as a Class II device.