# K973757: D.O.R.C. Solux Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Dutch Ophthalmic USA, Inc.
- Decided: Nov 7, 1997 after 36 days
- Product code: MPA (Endoilluminator)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963417 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963417: Vitlite (TR7700), Escalon Trek Medical (1996) Summary page 1.
- (no number) Grieshaber Light Source: named in the summary without a submission number

## Indications for use
The D.O.R.C. SOLUX Light Source is indicated for intraocular illumination in vitreoretinal surgery.

Source page: https://510kreport.com/device/K973757
Methodology: https://510kreport.com/methodology