510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K933976Substantially Equivalent

Mandelkorn Suture Lysis Lens

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

K933976 is the FDA 510(k) clearance record for MANDELKORN SUTURE LYSIS 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 K933976.

Clearance record

Decision date
Received
(452 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
510(k) summary
Statement
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