510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210300Substantially Equivalent

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

Vuesonic, LLC, Miami Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210300 is the FDA 510(k) clearance record for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System, a class II device, cleared for Vuesonic, LLC on under FDA product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses). FDA records list one 510(k) clearance for Vuesonic, LLC. As of , FDA records show no recalls naming K210300.

Clearance record

Decision date
Received
(57 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
Vuesonic, LLC 1234 Washington Ave., #205, Miami Beach FL
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