510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211361Substantially Equivalent

3N Contact Lenses Adjunct Cleaner

Suzhou 3N Biological Technology Co., Ltd., Suzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211361 is the FDA 510(k) clearance record for 3N Contact Lenses Adjunct Cleaner, a class II device, cleared for Suzhou 3N Biological Technology Co., Ltd. on under FDA product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses). FDA records list one 510(k) clearance for Suzhou 3N Biological Technology Co., Ltd. As of , FDA records show no recalls naming K211361.

Clearance record

Decision date
Received
(255 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
Suzhou 3N Biological Technology Co., Ltd. #218 Xinghu St., Suzhou, CN
510(k) summary
Summary PDF
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