510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991124Substantially Equivalent

Visijet Hydrokeratome, Model 50

Visijet, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991124 is the FDA 510(k) clearance record for VISIJET HYDROKERATOME, MODEL 50, a class I device, cleared for Visijet, Inc. on under FDA product code MYD (Keratome, Water Jet). FDA records list one 510(k) clearance for Visijet, Inc. As of , FDA records show no recalls naming K991124.

Clearance record

Decision date
Received
(567 days to decision)
Product code
MYD Keratome, Water Jet
Regulation
21 CFR 886.4370
Device class
Class I
Review panel
Ophthalmic
Applicant
Visijet, Inc. 18732 Saginaw, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code MYD

Trailing 12 months

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

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