# K984611: Drager Sola Series, Models 1000/700/500/300

- Pathway: 510(k) (Abbreviated)
- Applicant: Drager Medizintechnik GmbH
- Decided: Mar 29, 1999 after 90 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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 no predicate by number.

## Most influential descendants
- K011693: Trumpf Surgical Lights, Models 301,501,701,1001 (2001), 2 descendants of its own
- K102758: Trulight 5520 and Trulight 5320 (2010), 0 descendants of its own
- K091246: Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M) (2009), 0 descendants of its own

## Indications for use
The Driiger Sola surgical lights (Sola 1000, 700, 500) are intended to locally illuminate an operating or examination area of the patient’s body with high intensity light. The Dréiger Sola 300 is intended to be used as an examination light or as a satellite light within a surgical lighting system.

Source page: https://510kreport.com/device/K984611
Methodology: https://510kreport.com/methodology