# K071180: Scintillant Surgical Light, Model 2644-01-0001

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Solutions Co., LLC
- Decided: Jun 20, 2007 after 51 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: 2 generations back to K961122 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041681: Atricure Dissector, AtriCure, Inc. (2004) Summary page 1.
- K041621: Liteport LP100 Surgical Illuminator, Medical Vision Industries, Inc. (2004) Summary page 1.
- (no number) VersaLight Multi-Function Surgical Illuminator: named in the summary without a submission number
- (no number) LightMat Surgical Illuminator: named in the summary without a submission number

## Most influential descendants
- K133425: Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light (2013), 0 descendants of its own

## Indications for use
The Scintillant Surgical Light is intended to provide localized illumination of surgical sites.

Source page: https://510kreport.com/device/K071180
Methodology: https://510kreport.com/methodology