Clearance Summary
GOTTEX SUNGLASSES received FDA 510(k) clearance under submission number K861021, sponsored by Private Eyes Sunglass 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 1986-06-17.
- Submission: K861021
- Applicant / Sponsor: Private Eyes Sunglass Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1986-06-17
Classification & Regulation
This clearance is catalogued under FDA product code HQG and 21 CFR 886.5844, within the Ophthalmic review panel as a Class I device.