# K243063: Myolight Microcurrent Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Raja Trading Company, Inc.
- Decided: Feb 10, 2025 after 136 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K011935 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232172: BTL-785BNF Handpiece, BTL Industries, Inc. (2023) Summary page 5.

## Indications for use
The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.

Source page: https://510kreport.com/device/K243063
Methodology: https://510kreport.com/methodology