Clearance Summary
DESIGNS FOR VISION FIBEROPTIC LIGHT received FDA 510(k) clearance under submission number K032283, sponsored by Designs For Vision, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-08-20.
- Submission: K032283
- Applicant / Sponsor: Designs For Vision, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2003-08-20
Classification & Regulation
This clearance is catalogued under FDA product code GDB and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.