# K201191: Elec-Led

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Nx Co., Ltd.
- Decided: Feb 7, 2022 after 644 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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 K964860 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042759: Optima MX, Bien-Air SA Switzerland (2004) Summary page 4.

## Most influential descendants
- K251407: Motor Handpiece and Control Unit (SDI10) (2026), 0 descendants of its own

## Indications for use
The ELEC-LED is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.

Source page: https://510kreport.com/device/K201191
Methodology: https://510kreport.com/methodology