Venus BlissMAX

{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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 12, 2022 Venus Concept USA Inc. Nadav Reuben Senior Director RA & OA 1880 N Commerce Pkwy, Suite 2 Weston, Florida 33326 Re: K213308 Trade/Device Name: Venus BlissMAX Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX, PKT, NGX Dated: November 14, 2021 Received: November 17, 2021 Dear Nadav Reuben: 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 {1}------------------------------------------------ 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 (OS) 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, for Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213308 Device Name VENUS BlissMAX DEVICE Indications for Use (Describe) The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses: - · Relief of minor muscle aches and pain, relief of muscle spasm - · Temporary improvement of local blood circulation - · Temporary reduction in the appearance of cellulite In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles. The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------|---------------------------------------------| |----------------------------------------------|---------------------------------------------| #### 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}------------------------------------------------ # 510(k) SUMMARY #### K213308 #### VENUS BlissMAX DEVICE - Applicant Name: Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston, FL33326, USA Tel: +972-524211666 - Nadav Reuben, Contact Person: Senior Director RA & QA Venus Concept Ltd. - Date Prepared: January 10, 2022 Common/Usual/Trade Name: Venus BlissMAX device | <b>Regulation Numbers:</b> 21 CFR 878.5400 | |--------------------------------------------| | 21 CFR 878.4400 | | 21 CFR 890.5850 | - Classification Names: Laser For Disruption Of Adipocyte Cells For Aesthetic Use Massager, Vacuum, Radio Frequency Induced Heat Stimulator, Muscle, Powered, For Muscle Conditioning - Product Codes: PKT, PBX, NGX - Classification: Class II Medical Device - Classification Panel: Physical Medicine - Predicate Devices: Venus Bliss (K190743) Body System (K182440) - Reference Devices: InMode System with Tone Applicator (K192249) {4}------------------------------------------------ #### Intended Use/Indication for Use: The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses: - Relief of minor muscle aches and pain, relief of muscle spasm - Temporary improvement of local blood circulation - Temporary reduction in the appearance of cellulite ● In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles. The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional. ## Device Description: The Venus BlissMAX device is a computerized system comprised of a system console (main unit), four (4) Diode Laser applicators, one (1) MP2 (RF+ PEMF+ Vacuum) applicator and four (4) FlexMAX (EMS) applicators. The system delivers laser, bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of laser power, EMS intensity level, and RF power, in addition to vacuum levels, for each patient. The console of the Venus BlissMAX device contains a power supply unit, Laser, RF, and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel. The applicators are connected to the console via a cable. The RF applicator is comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits. The Laser applicators are comprised of a light guide, touch sensors and light-emitting diodes. The EMS applicator is comprised of two electrodes and a light indicator. {5}------------------------------------------------ #### Technological Characteristics: The Venus BlissMAX device delivers laser energy to the subcutaneous tissue layers via the four diode laser applicators connected to the console utilizes diode laser modules as sources of optical energy and the optical output is fiber-coupled through the applicator to the treatment area. The laser applicators are coupled to the patient's body while using a dedicated belt for the entire treatment. Individual adjustment of the laser output power is provided for each applicator to achieve maximum safety and efficiency for the patient. The laser applicators have an integrated contact skin cooling system to enhance safety and comfort of the treatment. In addition, the Venus BlissMAX device using the MP2 applicator provides RF treatments combined with emitted magnetic fields and vacuum massaging. The Vacuum is mainly used for the massaging of deep tissues by creating mild to deep suction. The vacuum massage improves the contact surface between electrodes and tissue. The RF currents heat the adipose and muscular tissues to trigger tissue level changes leading to temporary reduction in the appearance, of cellulite and temporary relief of muscle pain and muscle spasm. The RF heating effect also improves local blood circulation in the sub dermal layers. The PEMF assists in achieving treatment effect. Furthermore, The Venus BlissMAX device using the FlexMAX applicators (EMS applicators) contracts muscles by passing electrical currents through electrodes contacting the affected body area. The transcutaneous electrical current is designed to effect underlying, healthy muscles, causing them to contract. The FlexMAX applicators are coupled to the patient's body while using a dedicated belt during the entire treatment. The belt size and number of EMS applicators is determined by the treatment area and its size. Its use on muscles is in accordance with a class II device Powered Electrical Muscle Stimulator (Product Code NGX), based on the FDA guidance document for powered muscle stimulators for muscle conditioning as a special control1. ## Performance Data: Venus Concept conducted several performance tests to demonstrate that the Venus BlissMAX device complies with performance standards and that it functions as intended. - Performance Bench Testing: Several performance tests were performed, including software . validation and device verification tests in order to evaluate the Venus BlissMAX device's outputs per specifications. The results demonstrated that the differences in the technological characteristics of the subject and predicate devices do not raise new types of safety or effectiveness concerns. ¹ The Guidance for Industry, FDA Reviewers/Staff and Compliance Document for Powered Muscle Stimulator 510(k)s issued on June 9, 1999 {6}------------------------------------------------ - . Electrical Safety and Electromagnetic Compatibility: In addition, the device was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing. - . IEC 60601-1:2005+ Amd.1: 2012, Ed.3.1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-2-2 :2017 Ed. 6 Particular requirements for the basic safety and essential . performance of high frequency surgical equipment and high frequency surgical accessories - . IEC 60601-1-6: 2010+ Amd.1:2013 Ed.3.1, General requirements for basic safety and essential performance - Collateral standard: Usability - IEC 60601-2-10:2012+Amd.1:2016, Ed. 2.1, Medical electrical equipment Part 2-10: . Particular requirements for the basic safety and essential performance of nerve and muscle stimulators - . IEC 60601-1-2:2014 Ed. 4, General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - . IEC 60825-1:2014 Ed.3, Safety of laser products - Part 1: Equipment classification and requirements - IEC 60601-2-22:2007+Amd.1:2012 Ed. 3.1 Particular requirements for basic safety and • essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - IEC 62304:2006+Amd.1:2015 Ed.1.1, Medical device software Software life cycle . processes - Software Testing: The software was also subjected to verification and validation testing, and . results demonstrated that the system performed as intended. These performance tests demonstrated that the device meets the system requirements and do not raise new types of safety or effectiveness concerns. {7}------------------------------------------------ ## Substantial Equivalence: The following tables compare the Venus BlissMAX device to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence. #### Venus Concept, Ltd.'s Venus BlissMAX Substantial Equivalence Tables | | Proposed Device:<br>Venus BlissMAX<br>Venus Concept Ltd. | Predicate Device:<br>Venus Bliss<br>Venus Concept Ltd.<br>(K190743) | Substantial<br>Equivalence<br>Discussion | |-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | Classification<br>Product Code,<br>Regulation | Class II, PKT, 21 CFR 878.5400 | Class II, PKT, 21 CFR 878.5400 | Same | | Indications for Use | The Venus BlissMAX device is a diode<br>laser system intended for non-invasive<br>lipolysis of the abdomen and flanks in<br>individuals with a Body Mass Index (BMI)<br>of 30 or less. | The Venus Bliss device is a diode laser<br>system intended for non-invasive lipolysis<br>of the abdomen and flanks in<br>individuals with a Body Mass Index<br>(BMI) of 30 or less. | Same | | Lipolysis Method | Heat-assisted | Heat-assisted | Same | | Energy Used /<br>Delivered | Diode Laser | Diode Laser | Same | | Components | System Console<br>(with graphical user interface)<br><br>4 Applicators<br>- Sapphire light guides<br>- LED contact sensors | System Console<br>(with graphical user interface)<br><br>4 Applicators<br>- Sapphire light guides<br>- LED contact sensors | Same | | Wavelength | $1064 \pm 10$ nm (infrared) | $1064 \pm 10$ nm (infrared) | Same | | Spot Size | 6 x 6 cm2 on each of the Applicator heads | 6 x 6 cm2 on each of the Applicator heads | Same | | Operation Mode | CW | CW | Same | #### Table 1: Substantial Equivalence Table for the Diode Laser Applicators: {8}------------------------------------------------ | | Proposed Device:<br>Venus BlissMAX<br>Venus Concept Ltd. | Predicate Device:<br>Venus Bliss<br>Venus Concept Ltd.<br>(K190743) | Substantial<br>Equivalence<br>Discussion | |--------------------------|----------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------| | Power Density | Up to 1.4 W/cm² | Up to 1.4 W/cm² | Same | | Attachment to<br>Patient | Belt | Belt | Same | | Electrical Power | 100-240V~50/60 Hz, Single Phase | 100-240V~50/60 Hz, Single Phase | Same | | Cooling system | Distilled water or Venus Concept Chiller<br>Fluid | Distilled water or Venus Concept Chiller<br>Fluid | Same | | Materials | Biocompatible | Biocompatible | Same | | Sterility | Non-sterile | Non-sterile | Same | | | Table 2: Substantial Equivalence Table for the MP2 (RF+ PEMF +Vacuum) Applicators: | | | |--|------------------------------------------------------------------------------------|--|--| |--|------------------------------------------------------------------------------------|--|--| | | Proposed Device:<br>Venus BlissMAX<br>Venus Concept Ltd. | Predicate Device:<br>Venus Bliss<br>Venus Concept Ltd.<br>(K190743) | Substantial<br>Equivalence<br>Discussion | | 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| Classification,<br>Product Code,<br>Regulation | Class II, PBX, 21 CFR 878.4400 | Class II, PBX, 21 CFR 878.4400 | Same | | | Indications for Use | The Venus BlissMAX device is<br>intended for the treatment of the<br>following medical conditions; using<br>the MP2 applicator for delivery of RF<br>energy combined with massage and<br>magnetic field pulses:<br>Relief of minor muscle aches<br>and pain, relief of muscle<br>spasm Temporary improvement of<br>local blood circulation Temporary reduction in the<br>appearance of cellulite. | The Venus Bliss device is<br>intended for the treatment of the<br>following medical conditions; using<br>the MP2 applicator for delivery of RF<br>energy combined with massage and<br>magnetic field pulses:<br>Relief of minor muscle aches<br>and pain, relief of muscle<br>spasm Temporary improvement of<br>local blood circulation Temporary reduction in the<br>appearance of cellulite. | Same | | | | Proposed Device:<br>Venus BlissMAX<br>Venus Concept Ltd. | Predicate Device:<br>Venus Bliss<br>Venus Concept Ltd.<br>(K190743) | Substantial<br>Equivalence<br>Discussion | | | Energy Used /<br>Delivered | 1. RF Energy<br>2. Pulsed Electromagnetic Field (PEMF)<br>3. Vacuum | 1. RF Energy<br>2. Pulsed Electromagnetic Field (PEMF)<br>3. Vacuum | Same | | | Design | Use of RF and PEMF energies delivered through applicator with vacuum and massage of the skin. | Use of RF and PEMF energies delivered through applicator with vacuum and massage of the skin. | Same | | | Components | Console, including:<br>-Power supply<br>-RF generator<br>-Suction Module<br>-Main CPU<br>-Display panel<br>-PEMF generator<br>Applicator:<br>-MP2 | Console, including:<br>-Power supply<br>-RF generator<br>-Suction Module<br>-Main CPU<br>-Display panel<br>-PEMF generator<br>Applicator:<br>-MP2 | Same | | | Applicators | - MP2 applicator: comprised of 12 RF electrodes (8 peripheral and 4 internal), 8 PEMF coils covering the 8 peripheral RF electrodes, vacuum conduits | - MP2 applicator: comprised of 12 RF electrodes (8 peripheral and 4 internal), 8 PEMF coils covering the 8 peripheral RF electrodes, vacuum conduits | Same | | | Device Dimensions | 21.7x25.6x53.2 in<br>55x65x135 cm | 21.7x25.6x53.2 in<br>55x65x135 cm | Same | | | Applicator<br>Footprint<br>Dimensions | MP2: 38.5 cm2 | MP2: 38.5 cm2 | Same | | | Performance | Frequency: 1MHz<br>Vacuum pressure: -400mbar<br>Maximal RF output power: 100W<br>PEMF Power: 15 Gauss (15Hz) | Frequency: 1MHz<br>Vacuum pressure: -400mbar<br>Maximal RF output power: 100W<br>PEMF Power: 15 Gauss (15Hz) | Same | | | Materials | Biocompatible | Biocompatible | Same | | | Sterility | Non-sterile | Non-sterile | Same | | | Power<br>requirements | 100-120 VAC / 60Hz<br>220-240 VAC / 50Hz | 100-120 VAC / 60Hz<br>220-240 VAC / 50Hz | Same | | | | Proposed Device:<br>Venus BlissMAX<br>Venus Concept Ltd. | Predicate Device:<br>Body System<br>A-1 Engineering<br>(K182440) | Reference Device:<br>InMode System with<br>Tone Applicator<br>InMode Ltd.<br>(K192249) | Substantial Equivalence<br>Discussion | | Basic Unit Characteristics | | | | | | Classification<br>Product Code,<br>Regulation | Class II, NGX,<br>21 CFR 890.5850 | Class II, NGX,<br>21 CFR 890.5850 | Class II, IPF & GZJ,<br>21 CFR 890.5850 & 882.5890 | Same as the Predicate device | | Indications for<br>Use | The Venus BlissMAX device<br>using the FlexMAX<br>applicators is intended for<br>muscle conditioning to<br>stimulate healthy muscles.<br>The Venus BlissMAX device<br>using the FlexMAX<br>applicators is not intended to<br>be used in conjunction with<br>therapy or treatment of<br>medical diseases or medical<br>conditions of any kind.<br>The Venus BlissMAX device<br>using the FlexMAX<br>applicators is intended to be<br>operated by a trained<br>professional. | The Body System is intended<br>for muscle conditioning to<br>stimulate healthy muscles.<br>The Body System is not<br>intended to be used in<br>conjunction with therapy or<br>treatment of medical diseases or<br>medical<br>conditions of any kind.<br>The Body System is intended to<br>be operated by a trained<br>professional who is present to<br>monitor treatment. | The InMode System with Tone<br>Applicator is used in EMS<br>mode for:<br>- Prevention or retardation of<br>disuse atrophy<br>- Maintaining or increasing<br>range of motion<br>-Muscle re-education<br>- Relaxation of muscle spasms<br>- Increasing local blood<br>circulation<br>- Immediate postsurgical<br>stimulation of calf muscles to<br>prevent venous thrombosis<br>And in TENS mode for:<br>- Symptomatic relief and<br>management of chronic,<br>intractable pain<br>- Post-surgical acute pain<br>- Post-traumatic acute pain | Same as the Predicate device | | Components | The Venus BlissMAX device<br>consists of the following<br>components:<br>• Console, including a power<br>supply unit, controller and user<br>interface including an LCD<br>touch screen. | The body System is a Powered<br>Muscle Stimulator with 16<br>channel ports using self-<br>adhesive pad applicators<br>attached to the body for muscle<br>conditioning. | The InMode System consists<br>of the following components:<br>• Console, including a power<br>supply unit, controller and<br>user interface including an<br>LCD touch screen. | Similar to the Reference<br>device | | | Proposed Device:<br>Venus BlissMAX<br>Venus Concept Ltd. | Predicate Device:<br>Body System<br>A-1 Engineering<br>(K182440) | Reference Device:<br>InMode System with<br>Tone Applicator<br>InMode Ltd.<br>(K192249) | Substantial Equivalence<br>Discussion | | | • Several types of applicators<br>for different indications<br>(Laser, MP2, FlexMAX<br>applicators) connected to the<br>console via a cable. | | • Tone Applicator connected to<br>the console via a cable. | | | Mechanism of<br>Action | Muscle contraction by<br>electrical pulsing. | Muscle contraction by electrical<br>pulsing. | Muscle contraction by<br>electrical pulsing. | Same as the Predicate and<br>Reference devices | | Power Source | Main Line Frequency<br>(nominal): 50-60Hz<br><br>Input Voltage (nominal):<br>100-240VAC | Main Line Frequency<br>(nominal): 50-60Hz<br><br>Input Voltage (nominal):<br>110-240VAC | Main Line Frequency<br>(nominal) 50-60Hz<br><br>Input Voltage (nominal)<br>100-240VAC | Similar | | Method of Line<br>Current Isolation | Power Supply isolation | Power Supply isolation | Independent transformer<br>isolated | Same as the Predicate device | | Patient Leakage<br>Current | Normal condition:<br>1 μA<br><br>Single Fault condition:<br>11 μA | Normal condition:<br>0.05 μA<br><br>Single Fault condition:<br>0.05 μA | Normal condition:<br><100 μA<br><br>Single Fault condition:<br><300 μA | Similar<br>Complies with the FDA<br>Guidance on Powered<br>Muscle Stimulators and IEC<br>60601-2-10 standard<br>Normal condition: <100 μA<br>patient leakage<br>Single Fault condition: < 500<br>μA line leakage | | Number of Output<br>Modes | 1 | 5 | 2 | Different<br>The subject, predicate and<br>reference devices have a<br>similar output mode with<br>symmetrical biphasic pulses<br>that meets the requirements<br>of the FDA Guidance for<br>Powered Muscle Stimulators. | | Number of Output<br>Channels | 4 | 16 | 2 | Different<br>All channels for the<br>subject, predicate and | | | Proposed Device:<br>Venus BlissMAX<br>Venus Concept Ltd. | Predicate Device:<br>Body System<br>A-1 Engineering<br>(K182440) | Reference Device:<br>InMode System with<br>Tone Applicator<br>InMode Ltd.<br>(K192249) | Substantial Equivalence<br>Discussion | | Channel Output:<br>Synchronous or<br>Alternating | Synchronous | Synchronous | Not available | Same as the Predicate device | | Method of channel<br>isolation | Isolation transformer per<br>channel | Not available | Through transformers and<br>isolators | Similar | | Regulated<br>Current or<br>Regulated Voltage | Regulated voltage with current<br>limit | Both | Regulated voltage on all<br>channels with current limit | Same as the Predicate and<br>Reference devices (voltage<br>regulated devices) | | Software/<br>Firmware/<br>Microprocessor<br>Control | Yes | No | Yes | Similar to the Reference<br>device | | Automatic<br>Overload Trip | No | Yes | Yes | Different | | Automatic No<br>load Trip | No…