# K232172: BTL-785BNF Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Sep 18, 2023 after 59 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: 5 generations back to K011935 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191951: Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device, Avazzia, Inc. (2021) Summary page 5.

## Most influential descendants
- K243063: Myolight Microcurrent Handpiece (2025), 0 descendants of its own

## Indications for use
The BTL-785BNF Handpiece device has the following 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/K232172
Methodology: https://510kreport.com/methodology