510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950940Substantially Equivalent

Opti Pads

Karlen Mfg., Inc., St. Charles MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950940 is the FDA 510(k) clearance record for OPTI PADS, a class II device, cleared for Karlen Mfg., Inc. on under FDA product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses). FDA records list one 510(k) clearance for Karlen Mfg., Inc. As of , FDA records show no recalls naming K950940.

Clearance record

Decision date
Received
(119 days to decision)
Product code
LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Karlen Mfg., Inc. 5401 S Graham Rd., St. Charles MI
510(k) summary
Statement
Third party review
No

Clearances, product code LYL

Trailing 12 months

FDA records hold no clearances under product code LYL in the trailing twelve months.

FDA records show no clearances under product code LYL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260