| K-number | K253750 |
| Device name | BTL-785NEH |
| Applicant | BTL Industries, Inc. |
| Product code | GEI |
| Device class | Class II |
| Decision date | Mar 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4400 |
The BTL-785NEH is a radiofrequency, ultrasound, and electrostimulation platform consisting of a control unit with a color touchscreen and multiple applicators. It is intended to provide heating for pain relief, muscle spasm reduction, and increased local circulation; reduce cellulite appearance; perform dermatological and surgical electrocoagulation and hemostasis; reduce facial wrinkles; and affect the appearance of lax tissue in the submental and periorbital areas.
The BTL-785NEH operates at 3.2 MHz ± 5% (most applicators) or 1 MHz ± 5% (BTL-785-4 applicator), uses monopolar radiofrequency energy, and includes multiple applicators with integrated thermometers, ultrasonic preheating, massage attachments, microneedles (6×6 array), and hands-free electrodes. Output power ranges from 15 W to 140 W depending on applicator. Key differences from the predicate BTL-785S include removal of tips BTL-785-4-1, 4-2, 4-7, and 4-8, and adjusted maximum output power for BTL-785-4-3 (15 W vs. 20 W) and BTL-785-7 (57 W vs. 42.5 W).
The device complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-5, IEC 60601-1-6, IEC 62304, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, ISO 11135, ISO 11607-1, and ISO 11607-2.
The BTL-785NEH has the same technological characteristics, mode of action, and comparable intended use as the predicate BTL-785S (K233604). Any differences—primarily the removal of certain applicator tips and adjustments to maximum output power—have no significant influence on safety or effectiveness, establishing substantial equivalence to the predicate device.
View the full FDA submission: accessdata.fda.gov