Clearance Summary
LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) received FDA 510(k) clearance under submission number K936048, sponsored by Cogent Light Technologies, Inc.. 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 1994-03-10.
- Submission: K936048
- Applicant / Sponsor: Cogent Light Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1994-03-10
Classification & Regulation
This clearance is catalogued under FDA product code FST and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.