Who is the manufacturer of BTL-785X?

BTL Industries, Inc. filed the 510(k) submission for BTL-785X (K222556).

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

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-785X?

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

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

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-785X

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

BTL-785W (K211639); EXILIS 5000 (K092191).

K222556 · BTL Industries, Inc. · GEI · May 31, 2023 · General, Plastic Surgery

Device Facts

Record ID	K222556
Device Name	BTL-785X
Applicant	BTL Industries, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	May 31, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended 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: - 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. - non-invasive temporary reduction of facial wrinkles

Device Story

Radiofrequency (RF) system for therapeutic heating, electrocoagulation, hemostasis, and skin treatment. Inputs: user-selected parameters via 15.6" color touch screen. Operation: microprocessor-controlled RF generator delivers energy via five interchangeable applicators (BTL-785-1, -2, -3, -4, -7). Applicators integrate RF with ultrasound, massage, or muscle stimulation; BTL-785-4 uses microneedles/pins for fractional treatment. Output: thermal energy to tissue; visual feedback via illuminated treatment tips and screen. Used in clinical settings by professionals. Benefits: pain relief, muscle spasm reduction, improved circulation, cellulite appearance reduction, wrinkle reduction, and surgical hemostasis. Safety monitored via integrated thermometers and patient feedback.

Clinical Evidence

Clinical study (N=42) evaluated BTL-785-7 hands-free applicator for facial wrinkle reduction. Single-center, open-label, interventional design. Primary endpoint: reduction of at least 1.0 score on Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 3 months. Results: mean FWES improvement of 1.44 points (p<0.001). 100% of subjects satisfied/very satisfied; no adverse events reported.

Technological Characteristics

Monopolar RF generator; 1 MHz or 3.2 MHz frequency. System console with touch-screen interface. Applicators: BTL-785-1 (RF/ultrasound/massage), BTL-785-2 (RF/ultrasound), BTL-785-3 (RF), BTL-785-4 (RF microneedle/pins), BTL-785-7 (RF/muscle stimulation). Materials: biocompatible tips/electrodes. Sterilization: Ethylene oxide for single-use tips. Standards: IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-5, 60601-1-6, ISO 14971, ISO 10993 series, ISO 11135, ISO 11607.

Indications for Use

Indicated for patients requiring temporary relief of pain, muscle spasms, increased local circulation, temporary reduction of cellulite, electrocoagulation, hemostasis, fractional skin treatment, or non-invasive temporary reduction of facial wrinkles. BTL-785-4 applicator at >62 mJ/pin 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-785W (K211639)
EXILIS 5000 (K092191)

Related Devices

K253750 — BTL-785NEH · BTL Industries, Inc. · Mar 17, 2026
K211639 — BTL-785W · BTL Industries, Inc. · Mar 7, 2022
K233604 — BTL-785S · BTL Industries, Inc. · Mar 28, 2024
K193201 — BTL-785F · Btl · Aug 21, 2020
K252367 — InbellaMulti System · Inbella Medical, Inc. · Oct 15, 2025

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). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. May 31, 2023 BTL Industries Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752 #### Re: K222556 Trade/Device Name: Btl-785x Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: April 12, 2023 Received: May 3, 2023 #### 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. 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 {1}------------------------------------------------ 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 medical devices and radiation-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, Image /page/1/Figure/6 description: The image shows a digital signature. The signature is for Mark Trumbore -S. The date of the signature is 2023.05.31, and the time is 13:44:10 -04'00'. Mark Trumbore, 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) K222556 Device Name BTL-785X #### Indications for Use (Describe) 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: - 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. - non-invasive temporary reduction of facial wrinkles | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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 nested squares on the left side, with the letters "BTL" inside the innermost square. To the right of the squares is the text "BTL Industries" in a simple, sans-serif font. The logo is clean and modern, with a focus on geometric shapes and clear typography. # 510(k) Summary # K222556 ## General Information Classification Product Code: | 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: | May 29, 2023 | | Device | | | Trade/Proprietary Name: | BTL-785X | | Primary Classification Name: | Electrosurgical cutting and coagulation device and accessories | | Classification Regulation: | 21 CFR 878.4400, Class II | GEI, PBX {5}------------------------------------------------ ## Legally Marketed Predicate Device The BTL-785X 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-785W (K211639) ● - EXILIS 5000 (K092191) ● ## Product Description 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 #### Technological characteristics The BTL-785X device has identical technological characteristics compared to its predicate device. The BTL-785X device and the predicate are comprised of a system console and applicators. The system console consists of the RF generator, computer, and a touch-screen control panel. 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. {6}------------------------------------------------ - 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 hands-free applicator providing treatment by integration of radiofrequency heating and muscle stimulation resulting in induced muscle workout naturally increases local blood circulation. Suitable for the treatment of small and sensitive areas. The therapy is provided with single use electrodes only. 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. ## Indications for Use 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-785X 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-785X 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. {7}------------------------------------------------ The BTL-785X with BTL-785-7 hands-free applicator used with BTL-785-7-1 and BTL-785-7-2, singleuse 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. - . non-invasive temporary reduction of facial wrinkles. ## Performance Data The BTL-785X 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 | {8}------------------------------------------------ | ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements for | |----------------------------------------------------------|--------------------------------------------------------------------------------| | materials, sterile barrier systems and packaging systems | | - Packaging for terminally sterilized medical devices Part 2: Validation ISO 11607-2 requirements for forming, sealing and assembly processes ## BTL-785-7 applicator clinical performance data A clinical study was conducted to demonstrate the performance, clinical efficacy and safety of the BTL-785-7 hands-free applicator for non-invasive temporary reduction of wrinkles. This study has a single-center single-arm, open-label, interventional design. The study was conducted at a single site. All the enrolled participants were treated with the BTL-785-7 hands-free applicator. In total, N=42 subjects respected the study schedule and completed all the required study treatment visits and follow-up visits. No adverse events occurred throughout the whole clinical investigation. The study's primary efficacy endpoint was determined at the 3-month follow-up with three of the three blinded evaluators finding a statistically significant reduction of at least 1.0 score in the average score of FWES score at the 3-months follow-up compared to baseline. The average FWES score of the subjects showed an overall improvement of 1.44 points (p<0.001). The overall satisfaction with the study treatment outcome was high with all forty-two participants (100%) either satisfied (N=14, 33.3%) or very satisfied (N=28, 66.7%) at the 3-month follow-up. None of the patients was dissatisfied. Furthermore, 100% of the subjects found the procedure comfortable. Based on 3-month follow-ups, the treatment with the BTL-785X device equipped with applicator BTL-785-7 has shown to be both safe and effective for non-invasive temporary treatment of facial wrinkles with high satisfaction levels. {9}------------------------------------------------ ### The below table is a summary of the study design and results: | Study design | Single-center single-arm, open-label, interventional design | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sample size | 42 patients completed all study treatments and follow-up visits. | | Number of treatments and follow-up visits | 4 treatments and 2 follow-ups at 1 and 3 months | | Primary endpoints | To gather clinical evidence that BTL-785 system equipped with the BTL-785- 7 applicator is able to provide reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale score according to at least 2 out of 3 blinded dermatologists at 3- months follow-up compared to baseline. | | Secondary endpoints | Evaluation of the safety of the BTL-785 device with BTL-785-7 applicator for non-invasive reduction of wrinkles The majority of the treated subjects to report satisfaction (level satisfied and higher) with the therapy. | | Primary endpoint result | The average FWES score of the subjects showed an overall improvement of 1.44 points (p<0.001). | | Secondary endpoint results | No adverse events were recorded by the investigator during this clinical investigation neither during treatments, nor in the follow-up period. All forty-two participants (100%) were either satisfied (N=14, 33.3%) or very satisfied (N=28, 66.7%) at the 3-month follow-up. | {10}------------------------------------------------ ## Comparison with the Predicate Device | 510(k) number | K222556 | K211639 | K092191 | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | BTL-785X | BTL-785W | Exilis 5000 | | Company name | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. | | Type | Subject device | Primary predicate | Secondary predicate | | 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 | | Indications for Use | 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 | 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 | The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non- invasive treatment of wrinkles and rhytids. | {11}------------------------------------------------ | temporary reduction in the appearance of cellulite. | 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-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-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-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-785X 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-785-4-1, 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. | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares with the letters "BTL" inside them. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image contains 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 squares that are nested inside each other and slightly offset. | | Application of the heat to the tissue via RF energy. | Application of the heat to the tissue via RF energy. | Application of the heat to the tissue via RF energy. | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | Principle of Action | Massaging of body parts with massage attachment. (BTL-785-1 applicator only) Radiofrequency accompanied by electromagnetic stimulation (BTL-785-7 applicator only) | 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. | | Clinical Use | Prescription use | Prescription use | Prescription use | | 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, 5 A, 50/60 Hz 208-240 V AC, 2.5 A, 50 Hz | | Type of Energy Applied | Electromagnetic Energy - Radiofrequency | Electromagnetic Energy - Radiofrequency | Electromagnetic Energy - Radiofrequency | | 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, BTL-785- 7) 1 MHz ± 5% (BTL-785-4) | 3.25 Mhz ± 50 kHz N/A | | Mode of Operation | Monopolar | Monopolar | Monopolar | | User Interface | Color Touch-screen | Color Touch-screen | Color Touch-screen | {14}------------------------------------------------ Image /page/14/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 the letters "BTL" inside. | | 140 W (BTL-785-1-1) | 140 W (BTL-785-1-1) 125 W (BTL-785-1-2) | 170W | |-------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------| | | 62 W (BTL-785-2-1) | 62 W (BTL-785-2-1) 53 W (BTL-785-2-2) 62 W (BTL-785-2-3) | | | Maximum Output Power | 48 W (BTL-785-3-1) | 48 W (BTL-785-3-1) | | | | 30 W (BTL-785-4-1, 2, 5, 6) | 30 W (BTL-785-4-1, 2, 5, 6) | | | | 25 W (BTL-785-4-4, 8) | 25 W (BTL-785-4-4, 8) | | | | 20 W (BTL-785-4-3, 7) | 20 W (BTL-785-4-3, 7) | | | | 39.8 W (BTL-785-7) | 120 W (BTL-785-7) | | | Effective Treatment Temperature | 40 - 45°C (104 - 113°F) | 40 - 45°C (104 - 113°F) | 39 - 42°C (102 - 108°F) | | Skin Temperature Monitoring | Integrated thermometer + patient's feedback (BTL-785-1, 2, 3) | Integrated thermometer + patient's feedback (BTL-785-1, 2, 3) | Integrated thermometer + Skin temperature measurement | | Ultrasonic Tip Pre-heating Function | Yes (BTL-785-1, 2) | Yes (BTL-785-1, 2) | No | {15}------------------------------------------------ Image /page/15/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 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. | Massage Attachment | Yes (BTL-785-1) | Yes (BTL-785-1) | Yes | |------------------------------------------|---------------------------------------------------|---------------------------------------------------|-------------------------------------------------| | Number of Microneedles | 6 x 6 | 6 x 6 | N/A | | Handsfree applicator | Yes | Yes | N/A | | Depth of Microneedle Electrodes | 0.5 — 4 mm | 0.5 — 4 mm | N/A | | Number of Pins of Superficial Tips | 32 64 | 32 64 | N/A | | Sterilization Method | Ethylene oxide | Ethylene oxide | N/A | | Neutral Electrode Area | 169 cm² | 169 cm² | 118 cm² | | System Weight | 65 kg (143 lb) | 60 kg (132 lb) | 15.3 kg (33.7 lb) | | 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") | 230 x 390 x 260 mm (9.06" x 15.35" x 10.24") | #### New Indication for Use for Applicator BTL-785-7 The BTL-785X and its hands-free applicator BTL-785-7 are newly intended for non-invasive temporary reduction of facial wrinkles. This indication is supported by comparison with the primary and secondary predicate device and data from the clinical investigation. The new indication is proposed based on the {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking squares with the letters "BTL" inside the leftmost square. To the right of the squares is the text "BTL Industries" in a sans-serif font. The logo and text are both in a dark blue color. clinical trial's positive feedback from the participants, as well as the results achieved in the study. Additionally, the safety of the device has been evaluated during the clinical investigation and no new risks have been identified. We believe the difference does not raise any new questions of safety or effectiveness. #### Substantial Equivalence The BTL-785X device has the same technological characteristics and similar intended use compared to the primary predicate device and secondary predicate device. Any differences between the predicate devices and BTL-785X device have no significant influence on safety or effectiveness of the BTL-785X device. Therefore, the BTL-785X device is substantially equivalent to the predicate devices. ### Conclusion Based upon the intended use, comparison of technical characteristics and performance testing provided in this premarket notification, the BTL-785X device has been shown to be substantially equivalent to the currently cleared predicate device and secondary predicate device for requested intended use.