# K100702: Startrol Led Lighting Systems (X=# of Pods, Y=# of Leds, N=to Mounting Style) Model X X Y -N-S-W. X=Number of Light Pods

- Pathway: 510(k) (Traditional)
- Applicant: Huot Instruments, LLC
- Decided: Jul 20, 2010 after 130 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: 1 generation back to K003489 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003489: Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8, Medical Illumination International, Inc. (2001) Summary page 1.
- (no number) AIM: named in the summary without a submission number

## Indications for use
The StarTrol LED Lighting system is designed to provide a visible illumination of the examination /surgical field of the patient during surgical and non-surgical procedures.

Source page: https://510kreport.com/device/K100702
Methodology: https://510kreport.com/methodology