# K133062: Discovery System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Visual Systems
- Decided: Jun 20, 2014 after 266 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982057 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003299: Opd-Scan, Models Ark-10000 and Ark-9000, Nidek Co., Ltd. (2001) Summary page 2.
- K100202: Slit Lamp BO 900, BQ 900, BP900, Haag-Streit AG (2010) Summary page 2.

## Indications for use
The Discovery System is intended for use in: Mapping the lower and higher order aberrations of the eye which includes measurement of the spherical power, cylindrical power and cylinder axis. The measurement and analysis of corneal curvature (corneal refractive power), cylindrical power, and cylinder axis of the cornea. The device also maps the display of the corneal shape. White-to-white measurements (also called WTW or horizontal corneal diameter). Retro-illumination imaging of the anterior segment of the eye including intraocular lens imaging. The measurement of pupil diameter. In the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from -25.0 to +15.0 diopters spherical, and astigmatism from 0.0 to ± 10.0 diopters.

Source page: https://510kreport.com/device/K133062
Methodology: https://510kreport.com/methodology