# K031831: Topcon Model BV-1000 Automated Subjective Refraction System

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Systems, Inc.
- Decided: Dec 19, 2003 after 189 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 no predicate by number.

## Indications for use
The Topcon Model BV-1000 Automated Subjective Refraction System provides sphere, cylinder and axis measurements of the eye. The BV-1000 assists the eyecare professional in evaluating pre and post operative eye procedures and is used as an aid in prescribing eyeglasses and contact lenses.

Source page: https://510kreport.com/device/K031831
Methodology: https://510kreport.com/methodology