Clearance Summary
SOLA UV GARD(TM) SUNGLASSES received FDA 510(k) clearance under submission number K870997, sponsored by Sola-Syntex Ophthalmics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-05-29.
- Submission: K870997
- Applicant / Sponsor: Sola-Syntex Ophthalmics
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1987-05-29
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.