# K093010: Mach Led MC

- 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: 3 generations back to K965130 (1997). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061317: ILED, Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg (2006) Summary page 2.

## Most influential descendants
- K140461: Mach Led 2MC (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 MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light.

Source page: https://510kreport.com/device/K093010
Methodology: https://510kreport.com/methodology