Who is the manufacturer of Venus BlissMAX?

Venus Concept USA, Inc. filed the 510(k) submission for Venus BlissMAX (K220592).

What is the FDA product code for Venus BlissMAX?

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 Venus BlissMAX?

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

What are the predicate devices for Venus BlissMAX?

Venus Concept Venus BlissMAX (K213308); Cynosure SculpSure (K182741); Venus Concept Venus Legacy Pro (K191528).

Who can help prepare an FDA 510(k) submission like Venus BlissMAX?

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.

Venus BlissMAX

K220592 · Venus Concept USA, Inc. · PBX · Apr 27, 2022 · General, Plastic Surgery

Device Facts

Record ID	K220592
Device Name	Venus BlissMAX
Applicant	Venus Concept USA, Inc.
Product Code	PBX · General, Plastic Surgery
Decision Date	Apr 27, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen, flanks, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus BlissMAX device is intended for 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 Story

Computerized system comprising console, diode laser applicators, MP2 (RF, PEMF, vacuum) applicator, and FlexMAX (EMS) applicators. Laser applicators deliver 1064nm infrared energy for non-invasive lipolysis; MP2 applicator delivers bipolar RF, pulsed electromagnetic fields, and vacuum suction for muscle pain relief, circulation improvement, and cellulite reduction; FlexMAX applicators deliver transcutaneous electrical muscle stimulation (EMS) for muscle conditioning. Operated by trained professionals in clinical settings. Console features touch-screen interface, power supply, and controllers for energy delivery. Laser applicators use sapphire light guides and contact cooling; EMS applicators use electrodes. Output parameters (laser power, EMS intensity, RF power, vacuum levels) are adjustable per patient. Device uses belts to couple applicators to patient body. Output affects adipose and muscular tissues via thermal and electrical stimulation; benefits include body contouring, pain relief, and muscle conditioning.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including electrical safety, electromagnetic compatibility, and biocompatibility assessments.

Technological Characteristics

System includes console and three applicator types: diode laser (1064nm, fiber-coupled, contact cooling), MP2 (bipolar RF 1MHz, PEMF 15Hz, vacuum -400mbar), and FlexMAX (EMS, biphasic waveform). Materials are biocompatible. Connectivity via cable to console. Software-controlled energy delivery. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-22, IEC 60601-2-10, IEC 60825-1, IEC 62366.

Indications for Use

Indicated for non-invasive lipolysis (BMI ≤ 30) of abdomen, flanks, back, and thighs; relief of minor muscle aches/pain/spasm, temporary improvement of local blood circulation, and temporary reduction in cellulite appearance (via MP2 applicator); and muscle conditioning for healthy muscles (via FlexMAX applicators). Not for treatment of medical diseases/conditions. For use by trained professionals.

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

Venus Concept Venus BlissMAX (K213308)
Cynosure SculpSure (K182741)
Venus Concept Venus Legacy Pro (K191528)

Related Devices

K213308 — Venus BlissMAX · Venus Concept USA, Inc. · Jan 12, 2022
K190743 — Venus Bliss · Venus Concept USA, Inc. · Jun 25, 2019
K252845 — Venus Nova (FP-2001) · Venus Concept, Inc. · Nov 6, 2025
K250200 — InbellaBody System · Inbella Medical, Inc. · Feb 11, 2025
K231495 — The Evolve System with the Transform Applicator · InMode , Ltd. · Oct 13, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". April 27, 2022 Venus Concept USA Inc. William Mcgrail VP, Global Regulatory Affairs & Quality Assurance 1880 N Commerce Pkwy, Suite 2 Weston, Florida 33326 Re: K220592 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: February 24, 2022 Received: March 1, 2022 Dear William McGrail: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Purva Pandya, D.Eng. 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) K220592 Device Name Venus BlissMAX Indications for Use (Describe) The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen, flanks, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus BlissMAX device is intended for 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) | | |-------------------------------------------------|-----------------------------------------------| | 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. 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 (As Required by 21.CFR.807.92) | 1. SUBMITTER | | | |-----------------|----------------------------------|--| | Manufacturer: | Venus Concept USA, Inc. | | | | 1880 N Commerce Pkwy, Suite 2 | | | | Weston, FL 33326, USA | | | Contact Person: | William H. McGrail | | | | Vice President, Global RA & QA | | | | Venus Concept | | | | Phone: (978) 808-0420 | | | | Email: bmcgrail@venusconcept.com | | | Date Prepared: | April 27, 2022 | | ### 2. DEVICE INFORMATION | Trade/Device Name(s): | Venus BlissMAX System | |-------------------------|----------------------------------------------------------------| | Common or Unusual Name: | Venus BlissMAX System | | Regulation Number: | 21 CFR § 878.4400 21 CFR § 878.5400 21 CFR § 890.5850 | | Classification Name: | Electrosurgical Cutting And Coagulation Device And Accessories | | Regulation Class: | Class II | | Product Code: | PKT, PBX, NGX, | | Review Panel: | General & Plastic Surgery | ## 3. PREDICATE DEVICES | Primary Predicate: | Venus Concept Venus BlissMAX (K213308) | |-------------------------|------------------------------------------| | Co-Secondary Predicate: | Cynosure SculpSure (K182741) | | Co-Secondary Predicate: | Venus Concept Venus Legacy Pro (K191528) | {4}------------------------------------------------ #### 4. INDICATIONS FOR USE The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs 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 #### 5. 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}------------------------------------------------ #### 6. 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. ### 7. TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The following tables compare the Venus BlissMAX (Subject) device to the primary predicate: Venus BlissMAX (K213308) and co-secondary predicate: Cynosure SculpSure Laser System (K182741) and co-secondary predicate: Venus Legacy Pro (K191528) devices with respect to intended use, technological characteristics, and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence. 1 The Guidance for Industry, FDA Reviewers/Staff and Compliance Guidance Document for Powered Muscle Stimulator 510(k)s issued on June 9, 1999 {6}------------------------------------------------ | | Venus BlissMAX (Subject) | Venus BlissMAX (K213308) (Primary Predicate) | SculpSure Laser System (K182741) (Co-Secondary Predicate) | Substantial Equivalence Discussion | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------| | Manufacturer | Venus Concept | Venus Concept | Cynosure Inc. | Same as Primary Predicate Device | | Classification Product Code, Regulation | Class II, PKT, 21 CFR 878.5400 | Class II, PKT 21 CFR 878.5400 | Class II, PKT, 21 CFR 878.5400 | Same as both | | Indications for Use | The Venus BlissMAX device is a diode laser system intended for non- invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. | 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. | The SculpSure is intended for non- invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non- invasive lipolysis of the submental area in individuals with a BMI of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area. | Same as Co- secondary Predicate and Primary predicate Devices | | Lipolysis Method | Heat-assisted | Heat-assisted | Heat-assisted | Same as both | | Energy Used / Delivered | Diode Laser | Diode Laser | Diode Laser | Same as both | | Components | Console with GUI 4 Applicators - Sapphire light guides - LED contact sensors | Console with GUI 4 Applicators - Sapphire light guides - LED contact sensors | Console with GUI 4 Applicators - Sapphire light guides - LED contact sensors | Same as both | | Wavelength | 1064 ± 10nm (infrared) | 1064 ± 10nm (infrared) | 1060 ± 20nm (infrared) | Same as both | | Spot Size | 6 x 6 cm2 on each of the Applicator heads | 6 x 6 cm2 on each of the Applicator heads | 4 x 6 cm2 on each of the Applicator heads | Same as Primary predicate Device | | Operation Mode | CW | CW | CW | Same as both | | | Venus BlissMAX (Subject) | Venus BlissMAX (K213308) (Primary Predicate) | SculpSure Laser System (K182741) (Co-Secondary Predicate) | Substantial Equivalence Discussion | | Power Density | Up to 1.4 W/cm2 | Up to 1.4 W/cm2 | Up to 1.4 W/cm2 | Same as both | | Attachment to Patient | Belt | Belt | Belt | Same as both | | Power Requirements | 100-240V~50/60 Hz, Single Phase | 100-240V~50/60 Hz, Single Phase | 100-240V~50/60 Hz, Single Phase | Same as both | | Materials | Biocompatible | Biocompatible | Biocompatible | Same as both | | Sterility | Non-sterile | Non-sterile | Non-sterile | Same as both | # Table 1: Substantial Equivalence Table for the Diode Laser Applicators {7}------------------------------------------------ ### Table 2: Substantial Equivalence Table for the MP2 (RF+ PEMF +Vacuum) Applicators | Manufacturer | Venus BlissMAX (Subject) | Venus BlissMAX (K213308) (Primary Predicate) | Venus Legacy Pro (K191528) (Co-Secondary Predicate) | Substantial Equivalence Discussion | |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Venus Concept | Venus Concept | Venus Concept | Venus Concept | Same as both | | Classification Product Code, Regulation | Class II, PBX, 21 CFR 878.4400 21 CFR 878.5400 | Class II, PBX, 21 CFR 878.4400 21 CFR 878.5400 | Class II, GEI, PBX 21 CFR 878.4400 | Same as both | | Indications for Use | 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. | 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. | When used with the Octipolar (LB1) or Diamondpolar (LF1) applicators, the Venus Legacy Pro device is intended for use in dermatologic and general surgical procedures for females for the noninvasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV. When used with the 4D Body (LB2) and 4D Face (LF2) applicators, the Venus Legacy Pro device is intended for the delivery of non-thermal RF combined with Massage and magnetic field pulses for the treatment of the following medical conditions: • Relief of minor muscles aches and | Same as Primary predicate Device and similar to the Co-Secondary Predicate. | {8}------------------------------------------------ | | Venus BlissMAX (Subject) | Venus BlissMAX (K213308) (Primary Predicate) | Venus Legacy Pro (K191528) (Co-Secondary Predicate) | Substantial Equivalence Discussion | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | | | | pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite | | | Energy Used / Delivered | 1. RF Energy 2. Pulsed Magnetic Field (PMF) 3. Vacuum | 1. RF Energy 2. Pulsed Magnetic Field (PMF) 3. Vacuum | 1. RF Energy 2. Pulsed Magnetic Field (PMF) 3. Vacuum | Same as Primary predicate | | Applicator Footprint Dimensions | MP2: 38.5 cm2 | MP2: 38.5 cm2 | LB1: 23.7 cm2 LF1: 2.9 cm2 LB2: 38.5 cm2 LF2: 4.9 cm2 | Same as Primary predicate | | Performance | Frequency: 1MHz Vacuum pressure: - 400mbar Maximal RF output power: up to 150W PMF Power: 15 Gauss (15Hz) | Frequency: 1MHz Vacuum pressure: - 400mbar Maximal RF output power: up to 100W PMF Power: 15 Gauss (15Hz) | Frequency: 1MHz Vacuum pressure: - 400mbar Maximal RF output power: up to 150W PMF Power: 15 Gauss (15Hz) | Same as Co- Secondary Predicate device | | Materials | Biocompatible | Biocompatible | Biocompatible | Same as both | | Power Requirements | 100-120 VAC / 60Hz 220-240 VAC / 50Hz | 100-240V~50/60 Hz, Single Phase | 100-120 VAC / 60Hz 220-240 VAC / 50Hz | Same as both | {9}------------------------------------------------ | Table 3: Substantial Equivalence Table for the FlexMAX (EMS) Applicators: | |---------------------------------------------------------------------------| |---------------------------------------------------------------------------| | | Venus BlissMAX (Subject) | Venus BlissMAX (K213308) (Primary Predicate). | Substantial Equivalence Discussion | |-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------| | Basic Unit Characteristics | | | | | Classification Product Code, Regulation | Class II, NGX, 21 CFR 890.5850, | Class II, NGX, 21 CFR 890.5850 | Same | | Indications for Use | 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. | The Venus BlissMAX deviceusing the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles. The Venus BlissMAX deviceusing 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 deviceusing the FlexMAX applicators is intended to be operated by a trained professional. | Same | | Components | The Venus BlissMAX device consists of the following components: • Console, including a power supply unit, controller and user interface including an LCD touch screen. • Several types of applicatorsfor different indications (Laser, MP2, FlexMAX applicators) connected to theconsole via a cable. | The Venus BlissMAX device consists of the following components: • Console, including a power supply unit, controller and user interface including an LCD touch screen. • Several types of applicatorsfor different indications (Laser, MP2, FlexMAX applicators) connected to theconsole via a cable. | Same | | Mechanism of Action | Muscle contraction by electrical pulsing. | Muscle contraction by electrical pulsing. | Same | | Power Source | Main Line Frequency (nominal): 50-60Hz Input Voltage (nominal): 100- 240VAC | Main Line Frequency (nominal): 50-60Hz Input Voltage (nominal): 100- 240VAC | Same | | Method of Line Current Isolation | Power Supply isolation | Power Supply isolation | Same | | Patient Leakage Current | Normal condition:1 μA Single Fault condition:11 μA | Normal condition:1 μA Single Fault condition:11 μA | Same | | Number of Output Modes | 1 | 1 | Same | | Number of Output Channels | 4 | 4 | Same | | Channel Output: Synchronous or Alternating | Synchronous | Synchronous | Same | | Method of channel isolation | Isolation transformer per channel | Isolation transformer per channel | Same | | Regulated Current or Regulated Voltage | Regulated voltage with current limit | Regulated voltage with current limit | Same | | Software/ Firmware/ Microprocessor Control | Yes | Yes | Same | | Automatic EMS Shut off | Yes- Automatic EMStreatment shut off | Yes- Automatic EMStreatment shut off | Same | | Patient Override Control | Yes- Emergency button | Yes- Emergency button | Same | | Indicator Display: On / Off Status | Yes | Yes | Same | | Indicator Display: Voltage Current Level | Yes | Yes | Same | | Timer Range | Selectable 15, 30, 45, 60 min | Selectable 15, 30, 45, 60 min | Same | | Weight | 62 Kg / 136.7 lbs | 62 Kg / 136.7 lbs | Same | | Dimensions | 21.7 x 25.6 x 53.2 in 55 x 65 x 135 cm | 21.7 x 25.6 x 53.2 in 55 x 65 x 135 cm | Same | | Output Specifications | | | | | Waveform | Symmetrical Biphasicwaveform | Symmetrical Biphasicwaveform | Same | | Shape | Rectangular | Rectangular | Same | | Maximum Output Voltage | 40V@500Ω 105V@2kΩ 160V@10kΩ | 40V@500Ω 105V@2kΩ 160V@10kΩ | Same | | Maximum Output Current | 80 mA @ 500 Ω 52.5 mA @ 2 kΩ 16 mA @ 10 kΩ | 80 mA @ 500 Ω 52.5 mA @ 2 kΩ16 mA @ 10 kΩ | Same | | Frequency range | 1 Hz to 1000 Hz | 1 Hz to 1000 Hz | Same | | Pulse width range | 500 to 2500 [μs] | 500 to 2500 [μs] | Same | | Net Charge | 0 [μC] @ 500Ω Zero net charge is achieved by using symmetrical biphasic waveforms | 0 [μC] @ 500Ω Zero net charge is achieved by using symmetrical biphasic waveforms | Same | | Maximum Phase Charge | 40 [μC] @ 500Ω @ 1000 Hz | 40 [μC] @ 500Ω @ 1000 Hz | Same | | Maximum Current Density | 2.5 mA/cm² | 2.5 mA/cm² | Same | | Maximum Power Density | 55 [mW/cm²] @500Ω…