Clearance Summary
POLARIS SPECTACLE FRAMES & LENSES received FDA 510(k) clearance under submission number K802082, sponsored by Polaris Optics USA, 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 1981-02-13.
- Submission: K802082
- Applicant / Sponsor: Polaris Optics USA, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1981-02-13
Classification & Regulation
This clearance is catalogued under FDA product code HQY and 21 CFR 886.5850, within the Ophthalmic review panel as a Class I device.