# K000327: Wavescan Wavefront System Model HS 1

- Pathway: 510(k) (Traditional)
- Applicant: Visx, Incorporated
- Decided: May 2, 2000 after 90 days
- Product code: HKO (Refractometer, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.1760
- 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) Canon R-50m: named in the summary without a submission number

## Indications for use
The VISX WaveScan™ Wavefront System is a diagnostic instrument indicated for the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from +6.00 to —8.00 diopters spherical, and astigmatism from 0.00 to —6.00 diopters.

Source page: https://510kreport.com/device/K000327
Methodology: https://510kreport.com/methodology