Clearance Summary
EYEDENTITY EYEWEAR received FDA 510(k) clearance under submission number K872062, sponsored by Vitech Research C/O Johnsen, Manfredi & Thorpe. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-06-12.
- Submission: K872062
- Applicant / Sponsor: Vitech Research C/O Johnsen, Manfredi & Thorpe
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1987-06-12
Classification & Regulation
This clearance is catalogued under FDA product code HQZ and 21 CFR 886.5842, within the Ophthalmic review panel as a Class I device.