Clearance Summary
LENS, POLYCORE received FDA 510(k) clearance under submission number K790215, sponsored by Polycore Optical Pte , 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 1979-02-26.
- Submission: K790215
- Applicant / Sponsor: Polycore Optical Pte , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1979-02-26
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.