Clearance Summary
ROSE K POST GRAFT LENS received FDA 510(k) clearance under submission number K013646, sponsored by Rose K International , 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 2002-05-30.
- Submission: K013646
- Applicant / Sponsor: Rose K International , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 2002-05-30
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.