Clearance Summary
PROFESSIONAL DISINFECTION SYSTEM (PDS) received FDA 510(k) clearance under submission number K863346, sponsored by Ciba Vision Care. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-02-27.
- Submission: K863346
- Applicant / Sponsor: Ciba Vision Care
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 1987-02-27
Classification & Regulation
This clearance is catalogued under FDA product code LPN and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.