Clearance Summary
STARLIGHT, MODEL PD9012 received FDA 510(k) clearance under submission number K073317, sponsored by F.P. Rubinstein Y Cia S.R.L.. 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 2008-09-03.
- Submission: K073317
- Applicant / Sponsor: F.P. Rubinstein Y Cia S.R.L.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2008-09-03
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.