# K253750: BTL-785NEH

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Mar 17, 2026 after 112 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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.
No later device cites it as a predicate yet.
0 of 291 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.

## Indications for use
The BTL-785NEH device has the following indications for use: The BTL-785NEH with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785NEH with BTL-785-2 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785NEH with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature, for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785NEH with BTL-785-4 applicator used with tips BTL-785-4-5 and BTL-785-4-6 is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The BTL-785NEH with BTL-785-4 applicator used with tips BTL-785-4-3 and BTL-785-4-4 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin or microneedle, the use of the BTL-785-4 applicator is limited to Skin Types I-IV. The BTL-785NEH with BTL-785-7 Handpiece used with hands-free applicators: BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8, BTL-785-7-10, BTL-785-7-11 single-use applicators are intended to provide: Heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide: Non-invasive temporary reduction of facial wrinkles. BTL-785-7-9 single-use applicator is intended to: Affect the appearance of lax tissue in the submental area.

Source page: https://510kreport.com/device/K253750
Methodology: https://510kreport.com/methodology