# K991124: Visijet Hydrokeratome, Model 50

- Pathway: 510(k) (Traditional)
- Applicant: Visijet, Inc.
- Decided: Oct 20, 2000 after 567 days
- Product code: MYD (Keratome, Water Jet)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K935342 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983317: Barron Microkeratome System, Model B2000, Barron Precision Instruments, LLC (1998). Our OCR of the scanned summary read K973317, FDA’s number for Pasco Mic and Mic/ID Panels (Pasco Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Barron Microkeratome System Model B2000”.
- K971078: Hydrobrush (TM) Keratome, Medjet, Inc. (1998) Summary page 2.
- K913697: Automatic Corneal Shaper, Hansa Research & Development, Inc. (1991) Summary page 2.

## Indications for use
The VisiJet Hydrokeratome is indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K991124
Methodology: https://510kreport.com/methodology