510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971078Substantially Equivalent

Hydrobrush (Tm) Keratome

Medjet, Inc., Edison NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971078 is the FDA 510(k) clearance record for HYDROBRUSH (TM) KERATOME, a class I device, cleared for Medjet, Inc. on under FDA product code HQS (Burr, Corneal, Ac-Powered). FDA records list one 510(k) clearance for Medjet, Inc. As of , FDA records show no recalls naming K971078.

Clearance record

Decision date
Received
(305 days to decision)
Product code
HQS Burr, Corneal, Ac-Powered
Regulation
21 CFR 886.4070
Device class
Class I
Review panel
Ophthalmic
Applicant
Medjet, Inc. 1090 King Georges Post, #301, Edison NJ
510(k) summary
Statement
Third party review
No

Clearances, product code HQS

Trailing 12 months

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

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