# K093009: Mach Led SC

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Mach GmbH & Co. KG
- Decided: Apr 1, 2010 after 184 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
Longest line of descent: 4 generations back to K965130 (1997). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072072: Harmony Led-1 Surgical Lighting System, STERIS Corporation (2007) Summary page 2.
- K070442: Powerled Surgical Light System, Maquet S.A. (2007) Summary page 2.

## Most influential descendants
- K132307: Vida Led Surgical Lighting System (2013), 1 descendant of its own
- K140930: Vida Led Surgical Lighting System, V Series (2014), 0 descendants of its own
- K140460: Mach Led 2SC (2014), 0 descendants of its own
- K131893: Amico CE Series Surgical Lights, Mira Led Series Minor Surgical Lights (2013), 0 descendants of its own

## Indications for use
The surgical light Mach LED SC is intended to illuminate the surgical field and the patient.

Source page: https://510kreport.com/device/K093009
Methodology: https://510kreport.com/methodology