Clearance Summary
PolyDev Soft Contact Lenses received FDA 510(k) clearance under submission number K171157, sponsored by Polydev , 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 2017-06-02.
- Submission: K171157
- Applicant / Sponsor: Polydev , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2017-06-02
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.