# K973220: Rodenstock Laser Slitlamp

- Pathway: 510(k) (Traditional)
- Applicant: G. Rodenstock Instrumente GmbH
- Decided: Nov 4, 1997 after 69 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Zeiss SL 130 laser slitlamp fitted with the Zeiss Visulink Diode for use with the Zeiss Visulas Diode II argon laser: named in the summary without a submission number

## Most influential descendants
- K990665: BQ/BM Integrated Laser Delivery System (1999), 0 descendants of its own

## Indications for use
The Rodenstock RO 5000 AR, RO 5000 FDY, and RO 5000 AR/FDY Laser Slitlamps are indicated for diagnostic opthalmologic examination of patients with eye disorders. When interfaced with a laser, the device is used for therapeutic treatment of patients where retinal coagulation is indicated.

Source page: https://510kreport.com/device/K973220
Methodology: https://510kreport.com/methodology