# K971078: Hydrobrush (TM) Keratome

- Pathway: 510(k) (Traditional)
- Applicant: Medjet, Inc.
- Decided: Jan 23, 1998 after 305 days
- Product code: HQS (Burr, Corneal, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K991124: Visijet Hydrokeratome, Model 50 (2000), 0 descendants of its own

## Indications for use
Any condition which requires removal of the epithelium from the cornea.

Source page: https://510kreport.com/device/K971078
Methodology: https://510kreport.com/methodology