Benchmed logo
Categories

BTL-785NEH

BTL Industries, Inc.

Country / Region:United States (US)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Company

United States (US)

Product code

GEI
21 CFR 878.4400

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K253750
Device name
BTL-785NEH
Country / Region
United States(US)
Product code
GEI
Device class
Class 2
Regulation number
21 CFR 878.4400
Date received
2025-11-25
Decision date
2026-03-17
Submission type
Traditional
Technology type
RF Generator(AI inferred)
Clinical applications
Pain ManagementOther
Primary application
Pain Management
Classification source
AI classified

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.

Intended 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.

Device Description

The BTL-785NEH is a state-of-the-art radiofrequency, ultrasound and electrostimulation platform. The device is comprised of a control unit and applicators. The control unit of the system is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The device is accompanied by the following applicators: BTL-785-1 applicator providing treatment by integration of radiofrequency, ultrasound and active cooling. Suitable for the treatment of large body areas. BTL-785-2 applicator providing treatment by integration of radiofrequency and ultrasound. Suitable for the treatment of small areas. BTL-785-3 applicator providing radiofrequency treatment. The therapy is provided with single use tips only. BTL-785-4 applicator delivering radiofrequency via an array of microneedles and/or superficial pins. Therapy is provided with single use tips only. BTL-785-7 handpiece with hands-free applicators providing treatment by integration of radiofrequency heating and muscle stimulation resulting in induced muscle workout. Muscle workout naturally increases local blood circulation. Suitable for the treatment of face, neck and small and sensitive areas. The therapy is provided with single use electrodes only.

Summary parsed at:2026-06-19 06:02:51 UTC

Predicate devices

1

K253750 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K253750 as a predicate