Clearance Summary
COOL EYE(TM) EYE PROTECTOR received FDA 510(k) clearance under submission number K881135, sponsored by Cool Eyes, 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 1988-07-08.
- Submission: K881135
- Applicant / Sponsor: Cool Eyes, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4750
- Decision date: 1988-07-08
Classification & Regulation
This clearance is catalogued under FDA product code HOY and 21 CFR 886.4750, within the Ophthalmic review panel as a Class I device.