510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K864157Substantially Equivalent

Opti-Brush

Willmar Contact Lens Clinic, Willmar MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864157 is the FDA 510(k) clearance record for OPTI-BRUSH, a class II device, cleared for Willmar Contact Lens Clinic on under FDA product code LPN (Accessories, Soft Lens Products). FDA records list one 510(k) clearance for Willmar Contact Lens Clinic. As of , FDA records show no recalls naming K864157.

Clearance record

Decision date
Received
(21 days to decision)
Product code
LPN Accessories, Soft Lens Products
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Willmar Contact Lens Clinic 115 1/2 E. Litchfield Ave., Willmar MN
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