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 the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.

When used with the 4D Body (LB2) or 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 pain, relief of muscle spasm
Temporary improvement of local blood circulation
Temporary reduction in the appearance of cellulite

Device Description

The Venus Legacy Pro device consists of a console (main unit) and four applicators - Octipolar (LB1), Diamondpolar (LF1), 4D Body (LB2) and 4D Face (LF2). The console contains a power supply unit, an RF generator (power module, on main board), a suction module (vacuum), a controller unit (on main board) and a touchscreen user interface and display panel.

The Venus Legacy Pro device combines two previously cleared devices (Legacy BX, K142910 and Legacy CX. K143554) into one device. The two applicators that were cleared for the Legacy BX Device - Octipolar (LB1) and Diamondpolar (LF1) and the two applicators that were cleared for the Legacy CX device - 4D Body (LB2) and 4D Face (LF2) can now be connected simultaneously to a single console, the Legacy Pro device's console.

AI/ML Overview

The provided text describes the Venus Legacy Pro device, its intended uses, and its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, or effect size of human improvement with AI assistance.

Instead, the performance data presented focuses on engineering and regulatory compliance, not clinical outcomes.

Here's an analysis based on the information available in the text:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria for clinical performance (e.g., reduction in wrinkles by a certain percentage, pain relief score, cellulite reduction percentage). The "Performance Data" section primarily addresses engineering and regulatory compliance.

However, based on the bench tests mentioned, we can infer some performance targets for temperature control:

Acceptance Criteria (Inferred from Bench Tests)	Reported Device Performance
Ability of 4D Body (LB2) applicator to maintain skin surface temperature	Maintained appropriate desired treatment temperature of 41°C-45°C on the surface of the human skin.
Ability of 4D Face (LF2) applicator to maintain skin surface temperature	Maintained appropriate desired treatment temperature of 39°C-45°C on the surface of the human skin.
Software validation and device verification to evaluate Venus Legacy Pro device's outputs per specifications and compared to predicate device's specifications.	Results demonstrated that the differences in technological characteristics of the subject and predicate devices do not raise new types of safety or effectiveness concerns, and the software performed as intended.
Compliance with electrical safety and electromagnetic compatibility standards	All results were passing for IEC 60601-1:2012 Ed. 3.1, IEC 60601-2-2:2017 Ed. 6, IEC 60601-1-6: 2013 Ed.3, IEC 60601-1-2:2014 Ed. 4, and IEC 62304.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No information is provided regarding sample sizes for clinical test sets as the document focuses on technical performance and regulatory equivalence rather than clinical efficacy studies for this 510(k) submission. The "bench tests" mentioned are likely laboratory tests, not clinical studies with patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. The document discusses device safety, performance verification, and substantial equivalence to predicates, not the establishment of ground truth for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This information is relevant for clinical studies involving human assessment, which are not detailed in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI-assisted diagnostic or interpretation tool for human readers. It is a physical medical device for treatment.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm for standalone performance assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the bench tests, the "ground truth" would be the device's design specifications for temperature output, electrical safety, and electromagnetic compatibility. For clinical efficacy (e.g., wrinkle reduction, pain relief), the document does not describe studies that would establish such ground truth for the Venus Legacy Pro device. It relies on the indications for use of its predicate devices.

8. The sample size for the training set:

Not applicable. The document does not describe a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of what the document focuses on:

The entire document pertains to a 510(k) premarket notification for the Venus Legacy Pro Device. This type of submission primarily demonstrates substantial equivalence to a previously cleared predicate device, rather than performing de novo clinical efficacy trials to establish new acceptance criteria.

The "Performance Data" section discusses:

Bench Testing: To ensure the device's outputs meet specifications (e.g., temperature ranges for applicators) and are comparable to predicate devices.
Electrical Safety and Electromagnetic Compatibility: Compliance with international standards (IEC 60601 series).
Software Testing: Verification and validation to confirm the software performs as intended.

The acceptance criteria are therefore implicitly tied to meeting these engineering and regulatory standards, and demonstrating that any differences from the predicate devices do not raise new safety or effectiveness concerns. The study described is a series of engineering and regulatory compliance tests, not a clinical trial with human subjects to prove clinical efficacy against specific, measurable outcomes that would typically be described with metrics like sensitivity, specificity, or reader improvement.

Summary

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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 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.

September 6, 2019

Venus Concept USA Inc. % Elissa Burg Regulatory Consultant BioVision Ltd Had Nes 183 Had Nes, Israel 1295000

Re: K191528

Trade/Device Name: Venus Legacy Pro Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: June 6, 2019 Received: June 10, 2019

Dear Elissa Burg:

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.

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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.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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V. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K K191528

Device Name Venus Legacy Pro

Indications for Use (Describe)

Relief of minor muscles aches and pain, relief of muscle spasm ●
Temporary improvement of local blood circulation ●
Temporary reduction in the appearance of cellulite ●

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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510(k) SUMMARY - K191528

VENUS LEGACY PRO DEVICE

Applicant Name:	Venus Concept USA Inc. 1880N Commerce Pkwy, Suite 2Weston, FL33326, USA Tel:+972 - 549599215
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Contact Person: Dr. Yoni Iger VP QA/RA/CA Venus Concept USA Inc.
June 6, 2019 Date Prepared:
Trade Name: Venus Legacy Pro Device
Classification Name: Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400
Product Codes: GEI, PBX
Classification: Class II Medical Device
Classification Panel: General & Plastic Surgery
Venus Legacy BX (K142910) Predicate Devices: Venus Legacy CX (K143554)

Intended Use/Indication for Use:

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 temales for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.

· Relief of minor muscles aches and pain, relief of muscle spasm
Temporary improvement of local blood circulation
· Temporary reduction in the appearance of cellulite

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Device Description:

Technological Characteristics:

The Venus Legacy Pro device provides RF treatments combined with emitted magnetic fields via the Octipolar (LB1) and Diamondpolar (LF1) applicators and RF treatments combined with emitted magnetic fields and vacuum massaging via the 4D Body (LB2) and 4D Face (LF2) applicators. 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 dermal and sub dermal layers. The PMF assists in achieving treatment desired effect. The Vacuum is mainly used for the massaging of deep tissues by creating mild to deep suction. The vacuum massage contributes to the dermal, sub-dermal and adipose tissues shrinkage and improves the contact surface and electrical coupling between electrodes and tissue.

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Performance Data:

Venus Concept conducted several performance tests to demonstrate that the Venus Legacy Pro device complies with performance standards and that it functions as intended.

. Performance Bench Testing: Several performance tests were performed, includingsoftware validation and device verification tests in order to evaluate the Venus Legacy Pro device's outputs per specifications, and as compared to the predicate device's 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.
In addition, bench tests were conducted to demonstrate the ability of the LB2 and LF2 applicators operated by the Venus Legacy Pro device, to maintain the appropriate desired treatment temperature of 41°C-45°C on the surface of the human skin while using the 4D Body (LB2) applicator, and 39°C-45°C using the 4D Face (LF2) applicator
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 60601-1:2012 Ed. 3.1, Medical electrical equipment Part 1: Generalrequirements . 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: 2013 Ed.3, General requirements for basic safety and essential ● performance - Collateral standard: Usability
- IEC 60601-1-2:2014 Ed. 4, General requirements for basic safety and essential ● performance - Collateral Standard: Electromagnetic disturbances - Requirementsand tests
- IEC 62304 Medical device software Software life cycle processes (2006/AMD2015) .
. 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.

Substantial Equivalence:

The following table compares the Venus Legacy Pro 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.

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Table 1. Venus Concept, Ltd.'s Venus Legacv Pro Substantial Equivalence

	Venus Legacy ProVenus Concept Ltd.(K191528)	Venus Legacy BXVenus Concept Ltd.(K142910)	Venus Legacy CXVenus Concept Ltd.(K143554)
Class,ProductCode,Regulation	Class II, GEI & PBX, 21 CFR 878.4400	Class II, GEI, 21 CFR 878.4400	Class II, PBX, 21 CFR 878.4400
Indicationsfor Use	When used with the Octipolar (LB1) orDiamondpolar (LF1) applicators, theVenus Legacy Pro device is intended foruse in dermatologic and general surgicalprocedures for females for the non-invasive treatment of moderate to severefacial wrinkles and rhytides in Fitzpatrickskin types I-IV.When used with the 4D Body (LB2) and4D Face (LF2) applicators, the VenusLegacy Pro device is intended for thedelivery of non-thermal RF combinedwith Massage and magnetic field pulsesfor the treatment of the following medicalconditions:• Relief of minor muscles aches andpain, relief of muscle spasm• Temporary improvement of local bloodcirculation• Temporary reduction in the appearance of cellulite	The Venus Legacy BX is a non-invasive device intended for use indermatologic and general surgicalprocedures for females for the non-invasive treatment of moderate tosevere facial wrinkles and rhytides inFitzpatrick skin types I-IV.	The Venus Legacy CX device is intended forthe treatment of the following medicalconditions; using the LB2 and LF2applicators for delivery of non-thermal RFcombined with massage and magnetic fieldpulses:• Relief of minor muscle achesand pain, relief of muscle spasm• Temporary improvement of localblood circulation• Temporary reduction in theappearance of cellulite.

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	Venus Legacy ProVenus Concept Ltd.(K191528)	Venus Legacy BXVenus Concept Ltd.(K142910)	Venus Legacy CXVenus Concept Ltd.(K143554)
Energy Used / Delivered	1. RF Energy2. Pulsed Magnetic Field (PMF)3. Vacuum	1. RF Energy2. Pulsed Magnetic Field (PMF)	1. RF Energy2. Pulsed Magnetic Field (PMF)3. Vacuum
ApplicatorFootprintDimensions	LB1: 23.7 cm²LF1: 2.9 cm²LB2: 38.5 cm²LF2: 4.9 cm²	LB1: 23.7 cm²LF1: 2.9 cm²	LB2: 38.5 cm²LF2: 4.9 cm²
IntegralThermometer	Yes	Yes	Yes
Performance	Frequency: 1MHz	Frequency: 1MHz	Frequency: 1MHz
	Maximal RF output power foreach applicator -Octipolar (LB1), Diamondpolar(LF1), 4D Body (LB2) and 4D Face(LF2): up to 150W	Maximal RF output power for eachapplicator – Octipolar (LB1) &Diamondpolar (LF1): up to 150W	Maximal RF output power: 50W (4D Body(LB2) applicator), 20W (4D Body (LB2)applicator)
	PMF Power: 15 Gauss (15Hz)	PMF Power: 15 Gauss (15Hz)	PMF Power: 15 Gauss (15Hz)
	Vacuum pressure: -400mbar		Vacuum pressure: -400mbar
Materials	Materials are biocompatible	Materials are biocompatible	Materials are biocompatible
Powerrequirements	100-120 VAC / 60Hz220-240 VAC / 50Hz	100-120 VAC / 60Hz220-240 VAC / 50Hz	100-120 VAC / 60Hz220-240 VAC / 50Hz

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As described in the comparison table above, the Venus Legacy Pro device has the same intended use and a combination of the indications of the predicates previously cleared Venus devices. The device also has very similar technological characteristics compared to the predicate devices. The design and components in the Venus Legacy device, including the console and the applicators are similar to the design and components found in the predicates Legacy BX and Legacy CX devices. The technological differences, including the maximum output power for the 4D Body (LB2) and 4D Face (LF2) applicators and the difference in the applicator's biocompatible raw materials, do not alter the device's core technology or performance and do not raise new questions of safety and effectiveness.

Furthermore, the Venus Legacy Pro device underwent performance testing, including bench testing, Software validation testing, electrical safety according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2. These performance tests in addition to a bench test demonstrated that the differences in the technological characteristics between the subject and predicate devices do not raise new types of safety or effectiveness concerns.

Conclusions:

Based on the same intended use and indications for use, similar technological characteristics and principles of operation, the Venus Legacy Pro device is substantially equivalent to its predicate devices, Legacy BX (K142910) and Legacy CX (K143554).

Regulation Number and Section

§ 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.