510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011561Substantially Equivalent

Sereine Extra Strength Daily Cleaner

Wilsa, Inc., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011561 is the FDA 510(k) clearance record for SEREINE EXTRA STRENGTH DAILY CLEANER, a class II device, cleared for Wilsa, Inc. on under FDA product code LPN (Accessories, Soft Lens Products). FDA records list one 510(k) clearance for Wilsa, Inc. As of , FDA records show no recalls naming K011561.

Clearance record

Decision date
Received
(183 days to decision)
Product code
LPN Accessories, Soft Lens Products
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Wilsa, Inc. 2172 S. Jason St., Denver CO
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