Clearance Summary
THE ALBERTA LENS SM2, SULFOCON B received FDA 510(k) clearance under submission number K010454, sponsored by Progressive Optical Research , 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 2001-08-01.
- Submission: K010454
- Applicant / Sponsor: Progressive Optical Research , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 2001-08-01
Classification & Regulation
This clearance is catalogued under FDA product code HQD and 21 CFR 886.5916, within the Ophthalmic review panel as a Class II device.