Clearance Summary
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens received FDA 510(k) clearance under submission number K152657, sponsored by Smart Performer Corp. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2016-05-17.
- Submission: K152657
- Applicant / Sponsor: Smart Performer Corp. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2016-05-17
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.