Clearance Summary
ROSE K LENS received FDA 510(k) clearance under submission number K945955, 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 1995-02-07.
- Submission: K945955
- Applicant / Sponsor: Rose K International , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 1995-02-07
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.