Clearance Summary
ZIMLITE LENS received FDA 510(k) clearance under submission number K861960, sponsored by Asahi Optical Co. C/O Rosati Associates, P.C.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1986-06-09.
- Submission: K861960
- Applicant / Sponsor: Asahi Optical Co. C/O Rosati Associates, P.C.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1986-06-09
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.