510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K974485Substantially Equivalent

Sauflon All-in-One Light Contact Lens Solution

Szabocsik and Assoc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974485 is the FDA 510(k) clearance record for SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION, a class II device, cleared for Szabocsik and Assoc. on under FDA product code LPN (Accessories, Soft Lens Products). FDA records list 4 510(k) clearances for Szabocsik and Assoc., from to . As of , FDA records show no recalls naming K974485.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LPN Accessories, Soft Lens Products
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Szabocsik and Assoc. 203 N.Wabash, Suite 1200, Chicago IL
510(k) summary
Summary
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