Who is the manufacturer of BTL-785W?

BTL Industries, Inc. filed the 510(k) submission for BTL-785W (K211639).

What is the FDA product code for BTL-785W?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for BTL-785W?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BTL-785W?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BTL-785W

Q: What are the predicate devices for BTL-785W?

BTL-785F (K193201); EXILIS 5000 (K092191); TempSure System (K200241).

K211639 · BTL Industries, Inc. · GEI · Mar 7, 2022 · General, Plastic Surgery

Device Facts

Record ID	K211639
Device Name	BTL-785W
Applicant	BTL Industries, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Mar 7, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The BTL-785W 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-785W 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-785W 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-785W 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 hemostass. 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. The BTL-785-7 hands-free applicator of BTL-785W used with BTL-785-7-1, BTL-785-7-2, BTL-785-7-3 and BTL-785-7-4, BTL-785-7-5, BTL-785-7-6 single use electrodes 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.

Device Story

BTL-785W is a radiofrequency (RF) system for tissue heating, electrocoagulation, and muscle stimulation. Input: electrical power; Output: RF energy delivered via various applicators (BTL-785-1, 2, 3, 4, 7) to target tissue. System includes a microprocessor-controlled console with a 15.6" color touch screen for parameter setting and therapy guidance. Hand-pieces feature integrated buttons for control; treatment tips provide visual feedback on energy flow. Used in clinical settings by healthcare professionals. The BTL-785-7 applicator combines RF heating with electromagnetic muscle stimulation to induce muscle workout, increasing local circulation. Device monitors tissue temperature via integrated thermometers and patient feedback to maintain therapeutic range (40-45°C). Benefits include pain relief, muscle spasm reduction, and cosmetic skin improvements.

Clinical Evidence

Bench testing only. Performance data confirmed the BTL-785-7 applicator achieves and maintains superficial skin temperatures of 40-45°C. Electrical safety and electromagnetic compatibility verified per IEC 60601-1, 60601-1-2, 60601-2-2, and 60601-2-5. Biocompatibility, sterilization, and packaging validated per ISO 10993 and ISO 11135/11607 standards.

Technological Characteristics

System console with RF generator, computer, and 15.6" touch-screen interface. Applicators use monopolar RF (3.2 MHz for heating/stimulation, 1 MHz for surgical). Materials, size, and biocompatibility of RF tips match predicates. Sterilization via ethylene oxide. Software life cycle per IEC 62304. Energy source: 100-120V or 200-240V AC, 50/60 Hz.

Indications for Use

Indicated for patients requiring tissue heating for pain relief, muscle spasms, or increased local circulation; temporary reduction of cellulite appearance; dermatological/general surgical electrocoagulation and hemostasis; and fractional skin treatment. Higher energy fractional treatments limited to Skin Types I-IV.

Regulatory Classification

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.

Predicate Devices

BTL-785F (K193201)
EXILIS 5000 (K092191)
TempSure System (K200241)

Related Devices

K253750 — BTL-785NEH · BTL Industries, Inc. · Mar 17, 2026
K222556 — BTL-785X · BTL Industries, Inc. · May 31, 2023
K193201 — BTL-785F · Btl · Aug 21, 2020
K233604 — BTL-785S · BTL Industries, Inc. · Mar 28, 2024
K182363 — BTL-703 · BTL Industries, Inc. · Jan 24, 2019

Submission Summary (Full Text)

{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 and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below. March 7, 2022 David Chmel VP of Operations BTL Industries, Inc. 362 Elm Street Marlborough, Massachusetts 01752 Re: K211639 Trade/Device Name: BTL-785W Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: October 28, 2021 Received: November 29, 2021 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/cdrl/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. 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 {1}------------------------------------------------ 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211639 Device Name BTL-785W #### Indications for Use (Describe) The BTL-785W device has the following indications for use: The BTL-785W 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-785W 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-785W 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-785W 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 hemostass. 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. The BTL-785-7 hands-free applicator of BTL-785W used with BTL-785-7-1, BTL-785-7-2, BTL-785-7-3 and BTL-785-7-4, BTL-785-7-5, BTL-785-7-6 single use electrodes 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters "BTL" in white. The squares are arranged in a triangular pattern. 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: # Device | Trade/Proprietary Name: | BTL-785W | |------------------------------|----------------------------------------------------------------| | Primary Classification Name: | Electrosurgical cutting and coagulation device and accessories | | Classification Regulation: | 21 CFR 878.4400, Class II | | Classification Product Code: | GEI, PBX | March 4, 2022 {5}------------------------------------------------ Image /page/5/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 interlocking squares, each with the letters "BTL" inside. The text "BTL Industries" is written in a sans-serif font and is a dark gray color. # Legally Marketed Predicate Device The BTL-785W is a state-of-the-art radiofrequency device with accessories, and is substantially equivalent to the following products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers: - BTL-785F (K193201) ● - EXILIS 5000 (K092191) ● - TempSure System, (K200241), FlexSure single-use Applicator ## Product Description The BTL-785W 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-785W device comes with five different types of applicators. The BTL-785W 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 ● {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking blue squares on the left, with the letters "BTL" inside the squares. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look. ## Indications for Use The BTL-785W device has the following indications for use: The BTL-785W 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-785W 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-785W 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-785W with BTL-785-4 applicator 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-785W device used with tips BTL-785-4-3. 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-785W with BTL-785-7 hands-free applicator used with BTL-785-7-2, BTL-785-7-3, BTL-785-7-4, BTL-785-7-5 and BTL-785-7-6 single-use electrodes 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. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected squares with the letters "BTL" inside the leftmost square. To the right of the logo is the text "BTL Industries" in a sans-serif font. # Performance Data The BTL-785W 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 | | 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 | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three overlapping blue squares, each containing the letters "B", "T", and "L" respectively. To the right of the squares is the text "BTL Industries" in a dark gray, sans-serif font. ## BTL-785-7 applicator non-clinical performance data The new BTL-785-7 applicator was tested to achieve superficial skin temperature (40 - 45°C ) and maintain it for required therapy time. The testing data demonstrated that the device is capable to achieve therapeutic parameters substantially equivalent to the currently cleared predicate device for requested intended use. ## Technological Characteristics The BTL-785W device has similar technological characteristics compared to its predicate device. The BTL-785W device and the predicates are comprised of a system console and applicator(s). The system console consists of the RF generator, computer, and a touch-screen 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 devices have the same properties regarding their RF tips, including material, size, biocompatibility and sterilization method where applicable. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters B, T, and L. The squares are arranged in a row, with the first square slightly offset to the left. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. # Comparison with the Predicate Device | 510(k) number Device name Company name | K211639 BTL-785W BTL Industries, Inc. | K193201 BTL-785F BTL Industries, Inc. | K200241 TempSure System FlexSure single-use Applicator Cynosure, LLC Reference device | Significant difference | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | Product Code and Regulation | General & Plastic Surgery 21 CFR 878.4400 GEI - Electrosurgical, Cutting & Coagulation & Accessories PBX - Massager, Vacuum, Radiofrequency Induced Heat | General & Plastic Surgery 21 CFR 878.4400 GEI - Electrosurgical, Cutting & Coagulation & Accessories PBX - Massager, Vacuum, Radiofrequency Induced Heat | General & Plastic Surgery 21 CFR 878.4400 GEI - Electrosurgical, Cutting & Coagulation & Accessories PBX - Massager, Vacuum, Radiofrequency Induced Heat | None | | Indications for Use | The BTL-785W device has the following indications for use: The BTL-785W 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-785W with BTL-785-2 applicator is indicated to provide heating for the purpose of | 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 | The TempSure™ System has the following indications for use: The 10mm, 15mm, and 20mm Smart Handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The 18mm, 25mm, 30mm, 60mm Smart Handpieces and FlexSure™ applicators provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, | Not significant, please see discussion and conclusion below. | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each nested inside the other. # K211639 | elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. | elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. | muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | The BTL-785W 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-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- 785W 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- 785W 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. The BTL-785W with BTL-785-7 hands-free applicator used with BTL-785-7-1, BTL-785-7-2, BTL- 785-7-3, BTL-785-7-4, BTL-785-7- 5 and BTL-785-7-6 single-use | 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. | | | electrodes is intended to provide heating for the purpose of elevating tissue temperature for | | | {11}------------------------------------------------ Image /page/11/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 interlocking squares, each with a "B", "T", and "L" inside. The text "BTL Industries" is in a sans-serif font and is a dark gray color. | | selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. | | | | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------| | Principle of Action | Application of the heat to the tissue via RF energy. Massaging of body parts with massage attachment. (785-1 applicator only) Radiofrequency accompanied by electromagnetic stimulation (785-7 applicator only) | 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. | None | | | | | | | | | | | | | | Clinical Use | Prescription use | Prescription use | Prescription use | None | | Energy Source | 100 - 120 V AC, 50/60 Hz 200 - 240 V AC, 50/60 Hz | 100 - 120 V AC, 50/60 Hz 200 - 240 V AC, 50/60 Hz | 100 - 120 V AC, 50/60 Hz 200 - 240 V AC, 50/60 Hz | None | | Type of Energy Applied | Electromagnetic Energy - Radiofrequency | Electromagnetic Energy - Radiofrequency | Electromagnetic Energy - Radiofrequency | None | | Frequency | 3.2 MHz ± 5% (BTL-785-1, BTL-785-2, and BTL- 785-3, BTL-785-7) 1 MHz ± 5% (BTL-785-4) | 3.2 MHz ± 5% (BTL-785-1, BTL-785-2, and BTL- 785-3) 1 MHz ± 5% (BTL-785-4) | 4.0 MHz Sin-wave CW, Fully Rectified, Partially Rectified, and 1.7 MHz for Bipolar | Not significantly different | | Mode of Operation | Monopolar | Monopolar | Monopolar, Bipolar | None | | User Interface | Color Touch-screen | Color Touch-screen | Color Touch-screen | None | | Maximum Output Power | 125 W (BTL-785-1-2,) 140 W (BTL-785-1-1,) | 125 W (BTL-785-1-2) 140 W (BTL-785-1-1) | 300W (Surgical) 120W (Wrinkles) 300W (Tissue Heating) | Not significant, please see | | | 62 W (BTL-785-2-1) 53 W (BTL-785-2-2) 62 W (BTL-785-2-3) | 62 W (BTL-785-2-1) 53 W (BTL-785-2-2) 62 W (BTL-785-2-3) | | discussion and conclusion below. | | | 48 W (BTL-785-3-1) | 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) | 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 (BTL-785-7) | | | | | Effective Treatment Temperature | 40 - 45°C | 40 - 45°C | 42 - 44°C | not significant | | Skin Temperature Monitoring | Integrated thermometer + patient's feedback (BTL-785-1, 2, 3) | Integrated thermometer + patient's feedback (BTL-785-1, 2, 3) | Temperature-Sensitive Handpiece | None | | Ultrasonic Tip Pre-heating Function | Yes (BTL-785-1, 2) | Yes (BTL-785-1, 2) | Yes | None | | Massage Attachment | Yes (BTL-785-1) | Yes (BTL-785-1) | Yes | None | | Number of Microneedles | 6 x 6 | 6 x 6 | N/A | None | | Handsfree applicator | Yes | No | Yes | None | | Depth of Microneedle Electrodes | 0.5 - 4 mm | 0.5 - 4 mm | N/A | None | | Number of Pins of Superficial Tips | 32 64 | 32 64 | N/A | None | | Sterilization Method | Ethylene oxide | Ethylene oxide | N/A | None | | Neutral Electrode Area | 169 cm² | 169 cm² | 203 cm² | not significant | | System Weight | 60 kg (132 lb) | 60 kg (132 lb) | 13.6 kg (30 lb) - generator weight only | not significant | | System Dimension (W×H×D) | 1370 mm x 670 x 670 (53.94" x 26.38" x 26.38") | 1370 mm x 670 x 670 (53.94" x 26.38" x 26.38") | 450 x 310 x 580 mm (18" x 12" x 22.5") | not significant | ______________________________________________________________________________________________________________________________________________________________________________ {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each with a smaller square inside of it. # K211639 {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue 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 "BTL" inside the innermost square. The text "BTL Industries" is written in a sans-serif font and is also blue. K211639 {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares, each containing the letters "BTL". To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font. The overall design is modern and corporate. #### Introduction of New Applicator BTL-785-7 This submission introduces the new applicator BTL-785W with BTL-785-7 applicator used with BTL-785-7-1, BTL-785-7-2, BTL-785-7-3, BTL-785-7-5 and BTL-785-7-6 single-use electrodes 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. #### Maximum RF and Output Power and EMS (BTL-785-7 applicator) The maximum radiofrequency power as well as the maximum output power of the BTL-785-7 handsfree applicator is lower than the predicate. Nevertheless, the results of internal tests demonstrate that the device is able to achieve an equivalent treatment temperature and maintain it for the time required. The predicate device uses mechanical manipulation of the muscles. while the BTL-785-7 applies muscle stimulation resulting in induced muscle workout naturally increases local blood circulation. We believe the difference does not raise any new questions of safety or effectiveness. ## Substantial Equivalence The BTL-785W device has the same technological characteristics and similar intended use compared to the predicate device. Any differences between the predicate device and BTL-785W device have no significant influence on safety or effectiveness of the BTL-785W device. There are no technological modifications done to the device and its applicators compared to the predicate device. Therefore, the BTL-785W 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-785W device has been shown to be substantially equivalent to currently cleared predicate device for requested intended use.