# K123776: Polaris 100/200

- Pathway: 510(k) (Abbreviated)
- Applicant: Drager Medical GmbH
- Decided: Mar 8, 2013 after 88 days
- Product code: FTD (Lamp, Surgical)
- 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
Longest line of descent: 3 generations back to K965130 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010724: Sola 700,Sola 500, Sola 300, Drager Medizintechnik GmbH (2001) Summary page 3.
- K061317: ILED, Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg (2006) Summary page 3.

## Indications for use
Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms. Double light The combination of two operating lights as an operating light system enables the use in operating and treatment rooms. Versions - Polaris 100 light - Polaris 200 light

Source page: https://510kreport.com/device/K123776
Methodology: https://510kreport.com/methodology