Clearance Summary
ISIGHT received FDA 510(k) clearance under submission number K121519, sponsored by C&E GP Specialists, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2012-09-18.
- Submission: K121519
- Applicant / Sponsor: C&E GP Specialists, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2012-09-18
Classification & Regulation
This clearance is catalogued under FDA product code LPL and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.