# K092883: Led Lamp or Other

- Pathway: 510(k) (Traditional)
- Applicant: Intravista Medical Systems, Inc.
- Decided: Dec 18, 2009 after 91 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Vivid Light Tm LED lamps for slilt lamp biomicroscope are intended to be used as accessories for replacement of the GV Tungsten bulb for Haag Streit's BM900, BQ900, BX900 and BP900 slit lamp biomnicroscopes. Haag Streit's slit lamp biomicroscopes are indicated as noninvasive aid to the examination and diagnosis of eye conditions and in fitting of contact lenses.

Source page: https://510kreport.com/device/K092883
Methodology: https://510kreport.com/methodology