510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910231Substantially Equivalent

Nmr-K Fundus Laser Lens

Ocular Instruments, Inc., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910231 is the FDA 510(k) clearance record for NMR-K FUNDUS LASER LENS, a class II device, cleared for Ocular Instruments, Inc. on under FDA product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic). FDA records list 50 510(k) clearances for Ocular Instruments, Inc., from to . As of , FDA records show no recalls naming K910231.

Clearance record

Decision date
Received
(10 days to decision)
Product code
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Regulation
21 CFR 886.1385
Device class
Class II
Review panel
Ophthalmic
Applicant
Ocular Instruments, Inc. 2255 116th Ave., NE, Bellevue WA
Third party review
No

Clearances, product code HJK

Trailing 12 months

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

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