# K242532: BTL-785BNF-E

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Dec 13, 2024 after 109 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: 26 generations back to K943450 (1995). 290 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 292 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233604: BTL-785S, BTL Industries, Inc. (2024) Summary page 6.

## Most influential descendants
- K260945: Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) (2026), 0 descendants of its own

## Indications for use
The BTL-785BNF-E device has the following indications for use: The device is indicated for aesthetic use including facial and neck or body skin stimulation.

Source page: https://510kreport.com/device/K242532
Methodology: https://510kreport.com/methodology