Clearance Summary
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses received FDA 510(k) clearance under submission number K183200, sponsored by C&E GP Specialist, 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 2019-01-09.
- Submission: K183200
- Applicant / Sponsor: C&E GP Specialist, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 2019-01-09
Classification & Regulation
This clearance is catalogued under FDA product code MUW and 21 CFR 886.5916, within the Ophthalmic review panel as a Class II device.