510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K032309Substantially Equivalent

Novelens Contact Lens Cleaning Enhancement and Storage Accessory

Novelens, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032309 is the FDA 510(k) clearance record for NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY, a class II device, cleared for Novelens, Inc. on under FDA product code LRX (Case, Contact Lens). FDA records list one 510(k) clearance for Novelens, Inc. As of , FDA records show no recalls naming K032309.

Clearance record

Decision date
Received
(132 days to decision)
Product code
LRX Case, Contact Lens
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Novelens, Inc. 15825 Shady Grove Rd.Suite 30, Rockville MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LRX

Trailing 12 months
1 clearance under product code LRX in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LRX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260