510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863509Substantially Equivalent

Optec 1000 Dmv

Stereo Optical Company LLC, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863509 is the FDA 510(k) clearance record for OPTEC 1000 DMV, a class I device, cleared for Stereo Optical Co., Inc. on under FDA product code HOX (Chart, Visual Acuity). FDA records list 5 510(k) clearances for Stereo Optical Co., Inc., from to . As of , FDA records show no recalls naming K863509.

Clearance record

Decision date
Received
(62 days to decision)
Product code
HOX Chart, Visual Acuity
Regulation
21 CFR 886.1150
Device class
Class I
Review panel
Ophthalmic
Applicant
Stereo Optical Co., Inc. 3539 N. Kenton, Chicago IL
Third party review
No

Clearances, product code HOX

Trailing 12 months

FDA records hold no clearances under product code HOX in the trailing twelve months.

FDA records show no clearances under product code HOX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HOX, 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