# K962532: Rodenstock Slitlamp (Model 5000 & 4000)

- Pathway: 510(k) (Traditional)
- Applicant: Expertech Assoc., Inc.
- Decided: Jul 25, 1996 after 27 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
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) Haag-Streit brand slitlamp 900® BQ: named in the summary without a submission number
- (no number) Topcon brand slitlamp model SL-2ED: named in the summary without a submission number

## Indications for use
The device and accessories are indicated as a noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices.

Source page: https://510kreport.com/device/K962532
Methodology: https://510kreport.com/methodology