Clearance Summary
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM received FDA 510(k) clearance under submission number K050856, sponsored by Ophthocare , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2005-05-31.
- Submission: K050856
- Applicant / Sponsor: Ophthocare , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4750
- Decision date: 2005-05-31
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.