510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K863346Substantially Equivalent

Professional Disinfection System (Pds)

Ciba Vision Care, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863346 is the FDA 510(k) clearance record for PROFESSIONAL DISINFECTION SYSTEM (PDS), a class II device, cleared for Ciba Vision Care on under FDA product code LPN (Accessories, Soft Lens Products). FDA records list 2 510(k) clearances for Ciba Vision Care, from to . As of , FDA records show no recalls naming K863346.

Clearance record

Decision date
Received
(182 days to decision)
Product code
LPN Accessories, Soft Lens Products
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Ciba Vision Care P. O.Box 105069, Atlanta GA
Third party review
No

Clearances, product code LPN

Trailing 12 months
1 clearance under product code LPN in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LPN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260