Clearance Summary
POLARIS CONTACT LENS CASE received FDA 510(k) clearance under submission number K093377, sponsored by Reliance Design & Manufacturing Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2010-04-27.
- Submission: K093377
- Applicant / Sponsor: Reliance Design & Manufacturing Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2010-04-27
Classification & Regulation
This clearance is catalogued under FDA product code LRX and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.