(281 days)
The BTL-785X device has the following indications for use:
The BTL-785X 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-785X with BTL-785-2 applicator is indicated 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-785X 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-785-4 with BTL-785-4 applicator used with tips BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785X device used with tips BTL-785-4-4, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.
The BTL-785X with BTL-785-7 hands-free applicator used with forehead BTL-785-7-1 and cheek BTL-785-7-2 singleuse electrodes is intended to provide:
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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.
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non-invasive temporary reduction of facial wrinkles
The BTL-785X is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field.
The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785X device comes with five different types of applicators.
The BTL-785X device consists of the following main components:
- microprocessor-driven control unit
- radiofrequency generator
- user interface with 15.6" color touch screen
- applicators for an application of radiofrequency
- exchangeable applicator tips
Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided document:
Acceptance Criteria and Device Performance
The core acceptance criterion for the new indication (non-invasive temporary reduction of facial wrinkles) of the BTL-785X with the BTL-785-7 hands-free applicator was based on a statistically significant reduction in wrinkle severity.
| Acceptance Criterion (Primary Endpoint) | Reported Device Performance (Primary Endpoint Result) |
|---|---|
| A statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale (FWES) score according to at least 2 out of 3 blinded dermatologists at 3-months follow-up compared to baseline. | The average FWES score of the subjects showed an overall improvement of 1.44 points (p |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.