(275 days)
Not Found
No
The description focuses on standard radiofrequency technology, a microprocessor-driven control unit, and a user interface. There is no mention of AI, ML, or any features that would suggest their use in the device's operation or decision-making.
Yes
The device is intended to provide heating for the purpose of elevating tissue temperature for various medical conditions, including temporary relief of pain, muscle spasms, and increased local circulation. Some applicators are also indicated for temporary reduction in the appearance of cellulite, and dermatological/surgical procedures for electrocoagulation, hemostasis, and fractional skin treatment, all of which fall under therapeutic applications.
No
The "Intended Use / Indications for Use" section describes the device's function as providing heating for therapeutic purposes (e.g., pain relief, circulation increase, cellulite reduction, electrocoagulation, fractional skin treatment) and not for diagnosing any medical conditions.
No
The device description clearly outlines hardware components such as a control unit, radiofrequency generator, touch screen, applicators, and exchangeable tips. It is a physical device that utilizes software for control and user interface, but it is not solely software.
Based on the provided information, the BTL-785F device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The stated intended uses are for therapeutic purposes involving heating tissue for pain relief, muscle spasms, increased circulation, cellulite reduction, electrocoagulation, hemostasis, and fractional skin treatment. These are all procedures performed directly on or within the patient's body.
- Device Description: The description details a radiofrequency device with applicators and tips for applying therapy to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic information. The BTL-785F device's function is to apply energy directly to the patient's body for therapeutic and surgical purposes.
N/A
Intended Use / Indications for Use
The BTL-785F device has the following indications for use:
The BTL-785F 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-785F 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-785F 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 Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-1, 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-785F device used with tips 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, PBX
Device Description
The BTL-785F 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 quides 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-785F device comes with four different types of applicators.
The BTL-785F 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing has been performed in order to demonstrate that the device is able to achieve and maintain therapeutic temperature on different treated areas for at least 10min. Bench testing has been performed in order to demonstrate that the power output of the generator and geometry of the 785-4 applicator is identical to the same of the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 21, 2020
BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K193201
Trade/Device Name: BTL-785F Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: May 21, 2020 Received: May 26, 2020
Dear David Chmel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193201
Device Name BTL-785F
Indications for Use (Describe)
The BTL-785F device has the following indications for use:
The BTL-785F 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-785F 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-785F 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 Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-1, 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-785F device used with tips 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.
| X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C) | Type of Use (Select one or both, as applicable) | |
|---|---|---|
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking squares in blue, with the letters "BTL" inside the leftmost square. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.
510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | David Chmel
BTL Industries, Inc.
chmel@btlnet.com |
| Summary Preparation Date: | August 21, 2020 |
Device
| Trade/Proprietary Name: | BTL-785F |
|---|---|
| Primary Classification Name: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Classification Regulation: | 21 CFR 878.4400, Class II |
| Classification Product Code: | GEI, PBX |
4
Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each rotated 45 degrees, with the letters "BTL" inside the leftmost square. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font.
Legally Marketed Predicate Devices
The BTL-785F is a state-of-the-art radiofrequency device with accessories, and is substantially equivalent to the three current products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:
Product Description
The BTL-785F 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 quides 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-785F device comes with four different types of applicators.
The BTL-785F 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
Indications for Use
The BTL-785F device has the following indications for use:
The BTL-785F 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-785F 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.
5
Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.
The BTL-785F 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 Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-1, 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-785F device used with tips BTL-785-4-3. 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.
Performance Data
The BTL-785F device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard:
Electromagnetic disturbances - Requirements and tests |
| IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgery
equipment and high frequency surgical accessories |
| IEC 60601-2-5 | Medical electrical equipment - Part 2-5: Particular requirements for the
basic safety and essential performance of ultrasonic physiotherapy
equipment |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability |
| IEC 62304 | Medical device software - Software life cycle processes |
| ISO 14971 | Medical devices – Application of risk management to medical devices |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity |
| ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide
sterilization residuals |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritation
and skin sensitization |
6
Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three nested squares, with the letters "B", "T", and "L" inside the innermost square. The text "BTL Industries" is written in a sans-serif font and is gray in color.
| ISO 10993-11 | Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity |
|---|---|
| ISO 11135 | Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 11607-2 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
Bench testing has been performed in order to demonstrate that the device is able to achieve and maintain therapeutic temperature on different treated areas for at least 10min. Bench testing has been performed in order to demonstrate that the power output of the
generator and geometry of the 785-4 applicator is identical to the same of the predicate.
Technoloqical Characteristics
The BTL-785F device has similar technological characteristics compared to its predicate devices. The BTL-785F device and the predicates are comprised of a system console and applicator(s). The system console consists of the RF generator, computer, and the touchscreen control panel. The device is accompanied by four applicators enabling connection to exchangeable tips.
The compared devices' applicators use the RF signal of the same monopolar mode of operation, waveform and frequency. The maximum power intensity level of BTL-785F device in some cases differs to the predicates; nevertheless, based on the performance tests, the current device is able to reach the required treatment temperature and maintain it throughout the recommended treatment time. Therefore the current device is able to achieve substantial equivalent intended use based on identical mechanism of action.
The compared devices have similar properties regarding their RF tips, including material, size, biocompatibility properties and sterilization method where applicable.
The BTL-785F device is used with a larger neutral electrode compared to the predicate device. This approach prevents overheating and assures higher level of safety compared to the predicate device.
The differences do not raise any new questions of safety nor effectiveness.
7
Comparison with the Predicate Device
| 510(k) number | K193201 | K150720 | K092191 | K180359 | 1 MHz ± 5%
(BTL-785-4) | | | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------|-----------------------------------------|
| Device name | BTL-785F | XP3000 | Exilis 5000 | BTL-FR2000 | Mode of
Operation | Monopolar | Monopolar | Monopolar | Monopolar |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. | User Interface | Color Touch-screen
15.6" 1920x1080 px | Color Touch-screen
8.4" 640x480 px | Color Touch-screen
8.4" 640x480 px | Color Touch-screen
8.4" 640x480 px |
| | General & Plastic
Surgery
21 CFR 878.4400 | General & Plastic
Surgery
21 CFR 878.4400 | General & Plastic
Surgery
21 CFR 878.4400 | General & Plastic
Surgery
21 CFR 878.4400 | Maximum
Output Power | 125 W (BTL-785-1-2)
140 W (BTL-785-1-1)
62 W (BTL-785-2-1)
53 W (BTL-785-2-2)
62 W (BTL-785-2-3)
48 W (BTL-785-3-1)
30 W (BTL-785-4-1, 2,
5, 6)
25 W (BTL-785-5-4, 8)
20 W (BTL-785-4-3, 7) | 120 W (215/3)
170 W (215/1) | 170W | 30 W (N1, N2)
25 W (P2)
20 W (P1) |
| Product Code
and Regulation | GEI - Electrosurgical,
Cutting & Coagulation
& Accessories
PBX - Massager,
Vacuum,
Radiofrequency
Induced Heat | PBX - Massager,
Vacuum,
Radiofrequency
Induced Heat | GEI -
Electrosurgical,
Cutting &
Coagulation &
Accessories | GEI - Electrosurgical,
Cutting &
Coagulation &
Accessories | Effective
Treatment
Temperature | 40 - 45°C
(104 - 113°F) | 40 - 45°C
(104 - 113°F) | 39 - 42°C
(102 - 108°F) | 60 - 80°C
(140°F-176°F) |
| | Skin
Temperature
Monitoring | Integrated
thermometer +
patient's feedback
(BTL-785-1, 2, 3) | Integrated
thermometer +
patient's feedback
(Handpiece 215/1)
Based on patient's
feedback
(Handpiece 215/3) | Skin temperature
measurement | N/A | | | | |
| Indications for
Use | The BTL-785F device
has the following
indications for use:
The BTL-785F 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-785F 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-785F with
BTL-785-3 applicator
is intended to provide
heating for the
purpose of elevating | The XP3000 device
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
XP3000 massage
device is intended to
provide a temporary
reduction in the
appearance of
cellulite. | The EXILIS device is
indicated for the
primary treatment of
dermatologic and
general surgical
procedures for non-
invasive treatment of
wrinkles and rhytids. | The Applicator 786-1
of BTL-FR2000
device is indicated for
use in dermatological
and general surgical
procedures for
electrocoagulation
and hemostasis.
The Applicator 786-2
of BTL-FR2000
device is intended for
dermatological
procedures requiring
fractional treatment of
the skin. | The Ultrasonic
Tip Pre-heating
Function | Yes (BTL-785-1, 2) | No | No | No |
| | | | | | Massage
Attachment | Yes (BTL-785-1) | Yes | Yes | No |
| | tissue temperature for
selected medical
conditions such as
temporary relief of
pain, muscle spasms,
and increase in local
circulation.
The Applicator BTL-
785-4 of BTL-785F
device used with tips
BTL-785-4-1, 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-785F
device used with tips
BTL-785-4-3, 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. | | | | Number of
Microneedles | 6 x 6 | N/A | N/A | 6 x 6 |
| Principle of
Action | Application of the heat
to the tissue via RF
energy.
Massaging of body
parts with massage
attachment. (785-1
applicator only) | Application of the
heat to the tissue
via RF energy.
Massaging of body
parts with massage
attachment. | Application of the
heat to the tissue via
RF energy.
Massaging of body
parts with massage
attachment. | Delivering the RF
energy through the
skin results in an
electro-thermal
reaction. The heating
effect causes
collagen coagulation
and encourages
skin's natural healing
process. | Depth of
Microneedle
Electrodes | 0.5 - 4 mm | N/A | N/A | 0.5 – 3.5 mm |
| Clinical Use | Prescription use | Prescription use | Prescription use | Prescription use | Number of Pins
of Superficial
Tips | 32 | N/A | N/A | 32 |
| Energy Source | 100 - 120 V AC,
50/60 Hz
200 - 240 V AC,
50/60 Hz | 100 - 240 V AC,
50 – 60 Hz | 100-120 V AC, 5 A,
50/60 Hz
208-240 V AC, 2.5 A,
50 Hz | 100 - 240 V AC,
50 – 60 Hz | | 64 | N/A | N/A | 64 |
| Type of Energy
Applied | Electromagnetic
Energy -
Radiofrequency | Electromagnetic
Energy -
Radiofrequency | Electromagnetic
Energy -
Radiofrequency | Electromagnetic
Energy -
Radiofrequency | Sterilization
Method | Ethylene oxide | N/A | N/A | Ethylene oxide |
| Frequency | 3.2 MHz ± 5%
(BTL-785-1, BTL-785-
2, and BTL-785-3) | 3.25 MHz ± 50 kHz | 3.25 MHz ± 50 kHz | 1 MHz ± 5% | | | | | |
8
Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three overlapping squares with the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a sans-serif font. The logo is simple and modern.
9
Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing a letter of the company's name. The letters are white and are stacked on top of each other. To the right of the squares is the company's name in gray text.
10
Image /page/10/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking squares in blue, with the letters "BTL" inside the squares. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.
| Neutral
| Electrode Area | 169 cm² | 118 cm² | 118 cm² | 118 cm² |
|---|---|---|---|---|
| System Weight | 60 kg | |||
| (132 lb) | 30 kg | |||
| (66 lb) | 15.3 kg | |||
| (33.7 lb) | 7.3 kg | |||
| (16 lb) | ||||
| System | ||||
| Dimension | ||||
| (WxHxD) | 1370 mm x 670 x 670 | |||
| (53.94" x 26.38" | ||||
| x 26.38") | 1000 x 600 x 600 | |||
| mm | ||||
| (39.37" x 23.62" | ||||
| x 23.62") | 230 x 390 x 260 mm | |||
| (9.06" x 15.35" x | ||||
| 10.24") | 1000 x 600 x 600 mm | |||
| (39.37" x 23.62" | ||||
| x 23.62") |
Substantial Equivalence
The BTL-785F device has similar technological characteristics and intended use compared to the predicate devices. Any differences between the predicate devices and BTL-785F device have no significant influence on safety or effectiveness of the BTL-785F device. Therefore, the BTL-785F device is substantially equivalent to the predicate devices.
Conclusion
Based upon the intended use, comparison of technical characteristics and performance testing provided in this pre-market notification, the BTL-785F device has been shown to be substantially equivalent to currently marketed predicate devices for requested intended use.