# K133425: Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light

- Pathway: 510(k) (Special)
- Applicant: Engineered Medical Solutions Co., LLC
- Decided: Dec 5, 2013 after 27 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 K961122 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071180: Scintillant Surgical Light, Model 2644-01-0001, Engineered Medical Solutions Co., LLC (2007) Summary page 2.

## Indications for use
The Scintillant Surgical Lights are Intended to provide localized Illumination of surgical sites.

Source page: https://510kreport.com/device/K133425
Methodology: https://510kreport.com/methodology