(100 days)
No
The document describes a computerized system with various energy delivery modalities and a user interface for manual adjustment of parameters. There is no mention of AI, ML, or any adaptive or learning algorithms in the device description, intended use, or performance studies. The software testing mentioned is standard verification and validation, not indicative of AI/ML.
Yes
The device is intended for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite, all of which are considered therapeutic indications. The device also mentions a standard for "surgical, cosmetic, therapeutic and diagnostic laser equipment".
No
The Venus BlissMAX device is intended for non-invasive lipolysis, relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and muscle conditioning. Its intended uses are therapeutic/cosmetic, not diagnostic.
No
The device description explicitly states it 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." This indicates significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Venus BlissMAX Function: The Venus BlissMAX device is a system that applies various forms of energy (laser, RF, EMS, PEMF, vacuum) directly to the body for therapeutic and aesthetic purposes (lipolysis, muscle relief, circulation improvement, cellulite reduction, muscle conditioning). It does not analyze samples taken from the body.
The intended uses and device description clearly indicate that this is a therapeutic and aesthetic device, not a diagnostic one that analyzes biological samples.
N/A
Intended Use / Indications 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.
Product codes
PBX, PKT, NGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen and flanks
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional."
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Venus Bliss (K190743), Body System (K182440)
Reference Device(s)
InMode System with Tone Applicator (K192249)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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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
| Regulation Numbers: 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:
Venus BlissMAX
Venus Concept Ltd. | Predicate Device:
Venus Bliss
Venus Concept Ltd.
(K190743) | Substantial
Equivalence
Discussion |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Classification
Product Code,
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
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 Venus Bliss 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. | Same |
| Lipolysis Method | Heat-assisted | Heat-assisted | Same |
| Energy Used /
Delivered | Diode Laser | Diode Laser | Same |
| Components | System Console
(with graphical user interface)
4 Applicators
- Sapphire light guides
- LED contact sensors | System Console
(with graphical user interface)
4 Applicators
- Sapphire light guides
- 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:
Venus BlissMAX
Venus Concept Ltd. | Predicate Device:
Venus Bliss
Venus Concept Ltd.
(K190743) | Substantial
Equivalence
Discussion |
|--------------------------|----------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------|
| Power Density | Up to 1.4 W/cm² | Up to 1.4 W/cm² | Same |
| Attachment to
Patient | Belt | Belt | Same |
| Electrical Power | 100-240V50/60 Hz, Single Phase | 100-240V50/60 Hz, Single Phase | Same |
| Cooling system | Distilled water or Venus Concept Chiller
Fluid | Distilled water or Venus Concept Chiller
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:
Venus BlissMAX
Venus Concept Ltd. | Predicate Device:
Venus Bliss
Venus Concept Ltd.
(K190743) | Substantial
Equivalence
Discussion | |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification,
Product Code,
Regulation | Class II, PBX, 21 CFR 878.4400 | Class II, PBX, 21 CFR 878.4400 | Same | |
| 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 Bliss 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. | Same | |
| | Proposed Device:
Venus BlissMAX
Venus Concept Ltd. | Predicate Device:
Venus Bliss
Venus Concept Ltd.
(K190743) | Substantial
Equivalence
Discussion | |
| Energy Used /
Delivered | 1. RF Energy
2. Pulsed Electromagnetic Field (PEMF)
3. Vacuum | 1. RF Energy
2. Pulsed Electromagnetic Field (PEMF)
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:
-Power supply
-RF generator
-Suction Module
-Main CPU
-Display panel
-PEMF generator
Applicator:
-MP2 | Console, including:
-Power supply
-RF generator
-Suction Module
-Main CPU
-Display panel
-PEMF generator
Applicator:
-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
55x65x135 cm | 21.7x25.6x53.2 in
55x65x135 cm | Same | |
| Applicator
Footprint
Dimensions | MP2: 38.5 cm2 | MP2: 38.5 cm2 | Same | |
| Performance | Frequency: 1MHz
Vacuum pressure: -400mbar
Maximal RF output power: 100W
PEMF Power: 15 Gauss (15Hz) | Frequency: 1MHz
Vacuum pressure: -400mbar
Maximal RF output power: 100W
PEMF Power: 15 Gauss (15Hz) | Same | |
| Materials | Biocompatible | Biocompatible | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Power
requirements | 100-120 VAC / 60Hz
220-240 VAC / 50Hz | 100-120 VAC / 60Hz
220-240 VAC / 50Hz | Same | |
| | Proposed Device:
Venus BlissMAX
Venus Concept Ltd. | Predicate Device:
Body System
A-1 Engineering
(K182440) | Reference Device:
InMode System with
Tone Applicator
InMode Ltd.
(K192249) | Substantial Equivalence
Discussion |
| Basic Unit Characteristics | | | | |
| Classification
Product Code,
Regulation | Class II, NGX,
21 CFR 890.5850 | Class II, NGX,
21 CFR 890.5850 | Class II, IPF & GZJ,
21 CFR 890.5850 & 882.5890 | Same as the Predicate device |
| 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 Body System is intended
for muscle conditioning to
stimulate healthy muscles.
The Body System is not
intended to be used in
conjunction with therapy or
treatment of medical diseases or
medical
conditions of any kind.
The Body System is intended to
be operated by a trained
professional who is present to
monitor treatment. | The InMode System with Tone
Applicator is used in EMS
mode for:
- Prevention or retardation of
disuse atrophy - Maintaining or increasing
range of motion
-Muscle re-education - Relaxation of muscle spasms
- Increasing local blood
circulation - Immediate postsurgical
stimulation of calf muscles to
prevent venous thrombosis
And in TENS mode for: - Symptomatic relief and
management of chronic,
intractable pain - Post-surgical acute pain
- Post-traumatic acute pain | Same as the Predicate device |
| 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. | The body System is a Powered
Muscle Stimulator with 16
channel ports using self-
adhesive pad applicators
attached to the body for muscle
conditioning. | The InMode System consists
of the following components:
• Console, including a power
supply unit, controller and
user interface including an
LCD touch screen. | Similar to the Reference
device |
| | Proposed Device:
Venus BlissMAX
Venus Concept Ltd. | Predicate Device:
Body System
A-1 Engineering
(K182440) | Reference Device:
InMode System with
Tone Applicator
InMode Ltd.
(K192249) | Substantial Equivalence
Discussion |
| | • Several types of applicators
for different indications
(Laser, MP2, FlexMAX
applicators) connected to the
console via a cable. | | • Tone Applicator connected to
the console via a cable. | |
| Mechanism of
Action | Muscle contraction by
electrical pulsing. | Muscle contraction by electrical
pulsing. | Muscle contraction by
electrical pulsing. | Same as the Predicate and
Reference devices |
| Power Source | Main Line Frequency
(nominal): 50-60Hz
Input Voltage (nominal):
100-240VAC | Main Line Frequency
(nominal): 50-60Hz
Input Voltage (nominal):
110-240VAC | Main Line Frequency
(nominal) 50-60Hz
Input Voltage (nominal)
100-240VAC | Similar |
| Method of Line
Current Isolation | Power Supply isolation | Power Supply isolation | Independent transformer
isolated | Same as the Predicate device |
| Patient Leakage
Current | Normal condition:
1 μA
Single Fault condition:
11 μA | Normal condition:
0.05 μA
Single Fault condition:
0.05 μA | Normal condition: