# K131893: Amico CE Series Surgical Lights, Mira Led Series Minor Surgical Lights

- Pathway: 510(k) (Traditional)
- Applicant: Ajw Technology Consultants, Inc.
- Decided: Oct 30, 2013 after 127 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: 5 generations back to K965130 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093009: Mach Led SC, Dr. Mach GmbH & Co. KG (2010) Summary page 3.
- K093010: Mach Led MC, Dr. Mach GmbH & Co. KG (2010) Summary page 3.

## Indications for use
The intended use of the Amico ICE LED series surgical lights are to provide high intensity, shadow free illumination to the patient surgical field during surgical procedures. The intended use of the Amico Mira LED series minor surgery lights is to provide high intensity, shadow free illumination to the patient surgical field during Minor surgery procedures

Source page: https://510kreport.com/device/K131893
Methodology: https://510kreport.com/methodology