510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875197Substantially Equivalent

Optik-Aids/optic-Shop Thermal/therma Pro Lens Case

Pro-Optics LLC, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875197 is the FDA 510(k) clearance record for OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE, a class II device, cleared for Pro-Optics, Inc. on under FDA product code LRX (Case, Contact Lens). FDA records list one 510(k) clearance for Pro-Optics, Inc. As of , FDA records show no recalls naming K875197.

Clearance record

Decision date
Received
(54 days to decision)
Product code
LRX Case, Contact Lens
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Pro-Optics, Inc. C/O Hoogendoorn Talbot, Davids, Chicago IL
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