Clearance Summary
SOLARTEC SOURCE 270, MODEL # 90123 received FDA 510(k) clearance under submission number K983714, sponsored by Cogent Light Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1998-12-23.
- Submission: K983714
- Applicant / Sponsor: Cogent Light Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1998-12-23
Classification & Regulation
This clearance is catalogued under FDA product code FFS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.