Clearance Summary
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) received FDA 510(k) clearance under submission number K172314, sponsored by Art Optical Contact Lens, 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 2017-09-20.
- Submission: K172314
- Applicant / Sponsor: Art Optical Contact Lens, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 2017-09-20
Classification & Regulation
This clearance is catalogued under FDA product code HQD and 21 CFR 886.5916, within the Ophthalmic review panel as a Class II device.