Who is the manufacturer of Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

Capenergy Medical S.L. filed the 510(k) submission for Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 (K222260).

What is the FDA product code for Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

PBX. 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 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

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

Who can help prepare an FDA 510(k) submission like Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

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.

Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500

Q: What are the predicate devices for Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

Capenergy - C50, C100, C200, C300, C400 (K191202).

K222260 · Capenergy Medical S.L. · PBX · Mar 28, 2023 · General, Plastic Surgery

Device Facts

Record ID	K222260
Device Name	Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500
Applicant	Capenergy Medical S.L.
Product Code	PBX · General, Plastic Surgery
Decision Date	Mar 28, 2023
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

Capenergy C equipments RF System - C25, C50, C100, C200, C300 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation, and dermatological procedures. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite. Capenergy C equipments RF System - C25. C50. C100. C200. C300. C400. C500 are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Device Story

System generates RF energy via AC/DC power supply, RF generator, and controller; delivers energy to target tissue through conductive/capacitive electrodes on handpiece. System monitors tissue temperature and impedance via integrated thermocouple feedback loop; automatically adjusts energy delivery to maintain therapeutic set point (40-45°C). Used in clinical settings by healthcare professionals for dermatological and surgical procedures. Output provides controlled tissue heating for pain relief, muscle spasms, circulation, cellulite reduction, and hemostasis. Benefits include precise thermal regulation and safe tissue coagulation.

Clinical Evidence

Bench testing only. Testing confirmed device ability to reach and maintain therapeutic temperatures (40-45°C) on human skin for at least 10 minutes. Functional testing verified electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and software validation (IEC 62304). Biocompatibility of patient-contacting materials confirmed per ISO 10993-1.

Technological Characteristics

RF generator producing sinusoidal oscillating electric field; 0.448-1.2 MHz frequency range; 45W power output. System includes AC/DC power supply, controller, and handpiece with conductive/capacitive electrodes. Feedback loop uses thermocouple for temperature monitoring. Class I, Type BF safety protection. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2, IEC 62304, ISO 10993-1.

Indications for Use

Indicated for patients requiring topical heating for pain relief, muscle spasms, increased local circulation, temporary reduction in cellulite appearance, and dermatological/general surgical procedures requiring electrocoagulation and hemostasis.

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

Capenergy - C50, C100, C200, C300, C400 (K191202)

Reference Devices

Thermi Reusable Non-invasive RF Electrode (K171094)

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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. March 28, 2023 Capenergy Medical S.L. Pilar Sanchez General Manager Avinguda Mare de Déu de Montserrat, 41 Sant Joan Despi, Barcelona, Catalonia 08970 Spain Re: K222260 Trade/Device Name: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: January 29, 2023 Received: February 27, 2023 Dear Pilar Sanchez: 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 {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 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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.03.28 12:52:43 -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) K22260 Device Name Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 Indications for Use (Describe) Capenergy C equipments RF System - C25, C50, C100, C200, C300 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation, and dermatological procedures. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite. Capenergy C equipments RF System - C25. C50. C100. C200. C300. C400. C500 are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> 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. 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/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is a stylized graphic that includes an orange circle and blue lines. The overall design is clean and modern. CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission ### SECTION 05 - 510(k) SUMMARY | DATE OF SUBMISSION: | 2023-03-28 | |--------------------------|-----------------------------------------------------------------------------------------------------| | SUBMITTER NAME: | Capenergy Medical S.L. | | SUBMITTER ADDRESS: | Av. Mare de Deu de Montserrat, 41 bis Pje 1º derecha 08970 Sant Joan Despí Barcelona Spain | | CONTACT: | Pilar Sánchez General Manager | | TELEPHONE: | +34 93 477 43 48 | | e-mail: | pilar@capenergy.com | | DEVICE TRADE NAME: | Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 | | COMMON NAME: | Massager, Vacuum, Radio Frequency Induced Heat | | REGULATION DESCRIPTION: | General & Plastic Surgery | | CLASS: | Class II | | REGULATION NUMBER: | 21 CFR 878.4400 | | PRODUCT CODE: | PBX | | SUBSEQUENT PRODUCT CODE: | GEI | PREDICATE DEVICE Primary Predicate: Capenergy - C50, C100, C200, C300, C400 K191202 Reference Predicate(s): K171094 Thermi Reusable Non-invasive RF Electrode #### DEVICE DESCRIPTION: Capenergy C equipment's RF System - C25, C50, C100, C200, C300, C400, C500, including the hand piece, is a system generating RF energy with integral temperature and impedance feedback mechanism for procedures that require elevating tissue temperature. The Capenergy System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. Capenergy C equipment's RF System - C25, C50, C100, C200, C300, C400, C500 consists of an AC/DC power supply unit, RF generator, controller and user interface. The RF hand piece is {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is an orange circle with light blue lines emanating from it, resembling a stylized sun or energy source. CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission ## SECTION 05 - 510(k) SUMMARY connected to the console via a cable and a switch activates the energy delivery to the hand piece. The hand piece is comprised of conductive and capacitive electrodes. #### SUMMARY OF COMPARISON WITH PREDICATE DEVICE: In the establishment of substantial equivalence, Capenergy C Equipments RF Systems are compared with the following previously cleared devices: | Primary Predicate: K191202 | Capenergy - C50, C100, C200, C300, C400 | |------------------------------------|-------------------------------------------| | Reference Predicate(s): K171094 | Thermi Reusable Non-invasive RF Electrode | The comparison of the subject device with the primary predicate device is summarized in the following table {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is a graphic element consisting of an orange circle with blue lines radiating outward, resembling a stylized sun or energy source. CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission # SECTION 05 - 510(k) SUMMARY | Device Characteristic | Subject Device | Primary predicate Device | Secondary Predicate Device | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 including Set of Capenergy Reusable Non-invasive RF monopolar Electrodes | The Capenergy C Devices - C50, C100, C200, C300, C400 K191202 | Thermi Reusable Non-invasive RF Electrode K171094 | | FDA clearance | K222260 | K191202 | K171094 | | Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | | Product Code, Class | PBX Class II | PBX Class II | GEI Class II | | IFU | Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation | The Capenergy C Devices - C100, C200, C300, C400, C50, are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is | Thermi Temperature Controlled Radiofrequency (RF) System are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. | | The massage device provided is intended to provide a temporary reduction in the appearance of Cellulite Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. | intended to provide a temporary reduction in the appearance of cellulite | | | | Device Description | Capenergy RF generator produces an oscillating electric field in the antenna (electrode). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermocouple in the electrode measures this increase in temperature and maintains a feedback loop to ensure a set point temperature in the tissue. | Capenergy RF generator produces an oscillating electric field in the antenna (electrode). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermocouple in the electrode measures this increase in temperature and maintains a feedback loop to ensure a set point temperature in the tissue. | Thermi RF generator produces an oscillating electric field in the antenna (electrode). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermocouple in the electrode measures this increase in temperature and maintains a feedback loop to ensure a set point temperature in the tissue. | | RF Power | 45 W +/-10% for a charge of 06- j530 ohms to 1 MHz | 45 W +/-10% for a charge of 06-j530 ohms to 1 MHz | Up to 20 W | | Internal Cut-Off | 40-45°C | 40-45°C | 35-45°C | | Treatment Time | 15-660 sec | 15-660 sec | 15-120 sec | | | | | | | RF Frequency | Fixed values are established for the treatment time, percentage of power output and working frequency. There are four available options: 0.448 MHz +/-25% 0,8MHz +/-25% 1,0 MHz +/-25% 1,2 MHz +/-25% | Fixed values are established for the treatment time, percentage of power output and working frequency. There are three available options: 0,8MHz +/-25% 1,0 MHz +/-25% 1,2 MHz +/-25% | 0.46 MHz | | Waveform | Sinusoidal | Sinusoidal | Sinusoidal | | Safety Class Protection | Class I – Type BF | Class I - Type BF | Class I – Type BF | | Supply voltage and frequency | 100-120/200-240V ± 10%, 50/60 Hz | 100-120/200-240V ± 10%, 50/60 Hz | 100-120/200-240V ± 10%, 50/60 Hz | | Tissue impedance | 50 -300 Ohm | 50 -300 Ohm | 50 -300 Ohm | | Dimensions | 170 x 220 mm x 250 mm 345x 420 mm x 220 mm 562 mm x 420 mm x 220 mm | 345x 420 mm x 220 mm 562 mm x 420 mm x 220 mm | 149x 327x322mm (5,9 " x 12,9 " x 12,7 ") | | Weight | 3.5 - 22.5Kg | 3.5 - 22.5Kg | 15.8 lbs | {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for Capenergy. The text "CAPENERGY" is in a light blue sans-serif font. To the right of the text is an orange circle with blue lines emanating from it, resembling a stylized sun or energy symbol. CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission # SECTION 05 - 510(k) SUMMARY {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is an orange circle with light blue lines radiating outward, resembling a stylized sun or energy burst. The overall design is clean and modern, suggesting a company involved in energy or technology. CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission # SECTION 05 - 510(k) SUMMARY {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the logo for Capenergy. The logo consists of the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is a stylized graphic of an orange circle with blue lines radiating outward, resembling a sun or energy burst. The overall design is clean and modern. ## CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission # SECTION 05 - 510(k) SUMMARY | Compliance with voluntary standards / LAB tests performed | IEC 60601-1:2005 +/A1:2012 | IEC 60601-1:2005 +/A1:2012 | IEC 60601-1 | |-----------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------| | | IEC 60601-1-2:2015 | IEC 60601-1-2:2015 | IEC 60601-1-2 | | | IEC 60601-1-6:2010 | IEC 60601-1-6:2010 | IEC 60601-1-6 | | | IEC 60601-2-2: 2017 | IEC 60601-2-2: 2017 | IEC 60601-2-2 | | | IEC 62304:2006 | IEC 62304:2006 | ISO10993-1:2009 | | | ISO10993-1:2009 | ISO10993-1:2009 | | | Environmental conditions | Temperature: 10° to 40°C (+/- 20C) Relative humidity: less than 80%. | Temperature: 10° to 40°C (+/- 20C) Relative humidity: less than 80%. | Temperature: 10° to 40°C (+/- 20C) Relative humidity: less than 80%. | Table 1 Comparison with predicate and reference Device {9}------------------------------------------------ Image /page/9/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is an orange circle with light blue lines extending from it, creating a stylized design. CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission ## SECTION 05 - 510(k) SUMMARY ### INTENDED USE / INDICATIONS FOR USE: As established in the Indications for Use Statement: The Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation The massage device provided is intended to provide a temporary reduction in the appearance of cellulite. Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. ### SUMMARY DISCUSSION OF NON-CLINICAL DATA: The proposed device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as diathermia radiofrequency device. Based on the bench tests conducted, the device demonstrated ability to reach and maintain therapeutic temperature (40-45°C) on the surface of human skin for at least 10 minutes. Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including: - -Electrical safety - - Electromagnetic compatibility In addition to the electrical safety testing performed, software verification and validation was conducted to IEC 62304: 2006 - Medical device software - Software Life-Cycle Processes, and FDA guidance on software validation. The results of this testing conclude the software has met these requirements. Patient contacting materials have been evaluated according to the requirements of ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and confirmed to be biocompatible for their intended use. ### CONCLUSIONS: Based on the performance testing and comparison to predicate device, the Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 with their set of Capenergy Reusable Noninvasive RF monopolar Electrodes are substantially equivalent in terms of technology, function and {10}------------------------------------------------ Image /page/10/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue, sans-serif font. To the right of the text is an orange circle with blue lines emanating from it, possibly representing energy or movement. The overall design is clean and modern. CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission ## SECTION 05 - 510(k) SUMMARY intended use, to the devices in predicate Capenergy C Devices - C50, C100, C200, C300, C400, and the device in predicate Thermi Reusable Non-Invasive RF Electrode (monopolar).

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Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500

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