Clearance Summary
EYE COOLER received FDA 510(k) clearance under submission number K946231, sponsored by Direct Import Marketing Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-01-17.
- Submission: K946231
- Applicant / Sponsor: Direct Import Marketing Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1995-01-17
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.