# K984540: Keravision Vacuum Ring System

- Pathway: 510(k) (Abbreviated)
- Applicant: Keravision, Inc.
- Decided: Apr 28, 1999 after 128 days
- Product code: HNO (Keratome, Ac-Powered)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Chiron Vision Corp.’s Hansatome Microkeratome: named in the summary without a submission number
- (no number) Laser Light Technology, Inc.’s Automated Disposable Keratome (“ADK”): named in the summary without a submission number

## Indications for use
The KeraVision Intacs™ Vacuum System is indicated to fixate the eye and dissect the lamellae to create tunnels for placement of corneal ring segments to treat myopia.

Source page: https://510kreport.com/device/K984540
Methodology: https://510kreport.com/methodology