510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K040914Substantially Equivalent

Polyvial/polypak, Contact Lens Case and Storage System Container for Ophthalmics

Exero Products, Inc., Grand Junction CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040914 is the FDA 510(k) clearance record for POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS, a class II device, cleared for Exero Products, Inc. on under FDA product code LRX (Case, Contact Lens). FDA records list one 510(k) clearance for Exero Products, Inc. As of , FDA records show no recalls naming K040914.

Clearance record

Decision date
Received
(49 days to decision)
Product code
LRX Case, Contact Lens
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Exero Products, Inc. 623 Glacier Dr., Grand Junction CO
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