510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991965Substantially Equivalent

Purilens System for Cleaning and Disinfecting Contact Lenses

Purilens, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991965 is the FDA 510(k) clearance record for PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES, a class II device, cleared for Purilens, Inc. on under FDA product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses). FDA records list 2 510(k) clearances for Purilens, Inc., from to . As of , FDA records show no recalls naming K991965.

Clearance record

Decision date
Received
(113 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
Purilens, Inc. 12300 Twinbrook Pkwy., Suite 625, Rockville MD
510(k) summary
Summary
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