The Venus Versa System is a multi-application device intended to be used in aesthetic procedures. The SR515 and SR580 IPL applicators are indicated for the following:

Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations.

The HR650, HR690, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.

The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for the non-invasive treatment of moderate to severe facial wrinkles and rtides in Fitzpatrick skin types I-IV.

The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Device Description

The Venus Versa System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators). The system can deliver three types of energies to the patient's skin using the associated applicators:

Intense Pulsed Light (IPL); ●
Radiofrequency (RF); .
Magnetic Pulse (MP2). .

The following ten handpieces are included with the device system: SR515, SR580, HR650, HR690, HR650XL, HR690XL, ACDUAL, Diamondpolar, Octipolar, and Viva.

AI/ML Overview

The provided document is a 510(k) summary for the Venus Versa System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific clinical acceptance criteria through a standalone study with a predefined ground truth and expert adjudication. Therefore, much of the requested information (like specific acceptance criteria based on clinical efficacy, sample sizes for training/test sets, expert qualifications, or MRMC comparative effectiveness studies) is not typically found or required in a 510(k) summary for this class of device and type of submission.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and bench testing (system verification testing) rather than clinical performance data against specific endpoints.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described are largely related to technical specifications and safety, not clinical efficacy. The reported performance refers to the device meeting these technical specifications.

Acceptance Criteria (Technical/Safety)	Reported Device Performance
Electromagnetic Compatibility (EMC) per AAMI/ANSI ES60601-1, IEC 60601-1-2	All results were passing.
Electrical Safety per IEC 60601-2-2, and IEC 60601-2-57	All results were passing.
Biocompatibility of patient-contacting materials per ISO 10993-5	Established biocompatibility of materials; all results were passing.
Validation of cleaning, disinfection, and sterilization parameters	Validated in testing; all results were passing.
Software validation	Software was appropriate for release.
IPL Applicators:
Measured fluence at each wavelength matches expected value within defined acceptance criterion	Measured fluence levels at each wavelength were within expected values; passing results for each applicator (tested in 5 J/cm² increments).
Light guide temperatures meet expected values	Fluke measured temperatures of each applicator met specifications; passing results.
Spectral region defined by the filter for each wavelength (SR515, SR580, HR650, HR690, ACDUAL)	Test results demonstrated that the spectral region is defined by the filter; passing results.
Diamondpolar & Octipolar Applicators:
Measured RF voltage within expected values	Within expected values; met pass criteria.
Electromagnetic field density within expected values	Within expected values; met pass criteria.
System temperature within expected values	Within expected values; met pass criteria.
Viva Applicator:
Measured output power (pulse width, pulse amplitude) within expected values	Within expected values; met pass criteria.
Overall Versa applicators and system meet technical and mechanical requirements	All results were passing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe "test sets" in the context of clinical data for performance evaluation. The "testing" mentioned refers to engineering and safety verification on the device itself. Therefore, specific sample sizes for clinical test sets or data provenance (country, retrospective/prospective) are not applicable to the information provided for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable as the document describes technical verification and safety testing, not clinical studies requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (bench testing), not comparative clinical efficacy with human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

This information is not applicable as the Venus Versa System is a physical device (multi-application aesthetic system), not an AI algorithm. Its performance is inherent in its operation, not an "algorithm only" in the sense of AI.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation described would be engineering and manufacturing specifications/standards. For example, the "truth" for fluence measurement is the expected fluence value, and the "truth" for biocompatibility is conformance to ISO 10993-5. There is no clinical or pathological "ground truth" established from patient data mentioned in this submission for proving performance.

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is a physical system, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary of Device Acceptance and Study:

The Venus Versa System gained acceptance (clearance) through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices. The "study" proving this involves:

Comparison of Technical Characteristics: Showing that the Venus Versa System's intended use, indications for use, technological characteristics (energy type, IPL spectrum, frequency, spot size, pulse duration, energy density), and principles of operation are similar to its predicate devices, with minor differences that do not raise new safety or effectiveness concerns.
Bench Testing / System Verification: Conducting a series of engineering, safety, and performance evaluations on the device itself. This included:
- Electromagnetic Compatibility (EMC) testing.
- Electrical Safety testing.
- Biocompatibility testing of patient-contacting materials.
- Validation of cleaning, disinfection, and sterilization parameters.
- Software validation.
- Specific system verification for each applicator type (IPL, Bipolar RF & PMF, Fractional RF) to ensure measured outputs (e.g., fluence, RF voltage, output power, temperature) met predefined technical specifications and expected values.

In essence, the "acceptance criteria" were regulatory requirements for safety and performance equivalence to predicate devices, and the "study" was a combination of documentation outlining feature similarity and rigorous engineering verification testing. Clinical efficacy for specific indications, while implied by equivalence to predicates, was not proven through new clinical trials with patient cohorts described in this document.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 21, 2016

Venus Concept Ltd. % Janice Hogan Regulatory Counsel Hogan Lovells Us Llp 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K153717

Trade/Device Name: Venus Versa System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: ONF. GEX Dated: December 24, 2015 Received: December 24, 2015

Dear Ms. Hogan:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153717

Device Name Venus Versa System

Indications for Use (Describe)

The Venus Versa System is a multi-application device intended to be used in aesthetic procedures. The SR515 and SR580 IPL applicators are indicated for the following:

Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.

The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

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

Venus Concept's Venus Versa System

Sponsor/Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Venus Concept USA Ltd. 4556 N. Hiatus Road Sunrise, FL 33351 Telephone: 416.907.0115 Fax: 954.572.5680

Contact Person: Tal Bresler-Stramer, Ph.D., RAC VP QA/RA Venus Concept, Ltd.

Date Prepared: March 18, 2016

Trade Name of Device

Venus Versa System

Classification Regulation, Name, Product Code

Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810), Product Codes: ONF, GEX

Predicate/Reference Devices

Predicate Devices:

Danish Dermatologic Development A/S's Ellipse I-PL System (K060516) MATTIOLI Pulse TWO/THREE Plus Family (K100053) Global Medical Technology S.L.'s Platinum GMT IPL System Cloud (K140668) Venus Concept Ltd.'s Venus Legacy BX Device (K142910) Venus Concept Ltd.'s Viva SR Device (K150161)

Reference Devices:

Lumenis M22 System (K142860); Alma Laser's Harmony Lite Multi-Application Platform (K141237, K072564); Emvera Diolux (K123257); Lumenis Inc.'s LightSheer Duet Laser System (K053628); BTL's Exilite IPL system (K150051); Beijing KES Biology Technology's IPL System (K122995); Palomar Medical Products, Inc.'s StarLux Pulsed Light System (K041086); Beijing Syntech Laser Co.'s APOLLO V+ (K113018)

Intended Use / Indications for Use

The Venus Versa System is a multi-application device intended to be used in aesthetic and cosmetic procedures.

The SR515 and SR580 IPL applicators are indicated for the following:

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. Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.
. Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.

The HR650, HR650, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.

The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Device Description

Intense Pulsed Light (IPL); ●
Radiofrequency (RF); .
Magnetic Pulse (MP2). .

The following ten handpieces are included with the device system: SR515, SR580, HR650, HR690, HR650XL, HR690XL, ACDUAL, Diamondpolar, Octipolar, and Viva.

Technological Characteristics

The Venus Versa System has similar technological characteristics to its predicates. The Versa is a multi-application system that allows delivery of energy, similar to its predicates. The Versa and the predicate devices are each designed as a system console with a user interface and applicator(s) indicated for the desired treatment effects. The technological characteristics of the Venus Versa as a system and when used for each of the proposed indications (vascular lesions, pigmented lesions, hair removal/reduction, acne) are similar to the corresponding parameters of the predicate devices. The technological differences between the Venus Versa and its predicates are minor, including some minor differences in terms of the spot size, frequency, and pulse duration. However, the key parameters of the Versa affecting treatment outcomes (i.e., wavelengths, fluence levels, total energy) are the same or encompassed within the range of the predicate devices. Therefore, the dimensional differences or other technical differences between the Versa and its predicates do not present any new or different issues of safety or effectiveness. Therefore, the Venus Versa

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System presents similar technological characteristics as its predicates, in support of
substantial equivalence. See Table 1 below.

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Table 1. Venus Concept, Ltd.'s Venus Versa Substantial Equivalence Charts

Substantial Equivalence Table #1 for IPL Applicators: (1) SR515; (2) SR580; (3) HR650; (4) HR690; (5)HR650XL; (6) HR690XL; (7)
ACDUAL

MedicalDevice	Venus Concept Ltd.'sVenus Versa System –Full Configuration	Danish DermatologicDevelopment A/S EllipseI²PL System (K060516)	Mattioli Pulse TWO/THREEPlus Family (K100053)	Global Medical TechnologyS.L.'s Platinum GMT IPLSystem Cloud (K140668)
Class,ProductCode,Regulation	Class IIONF, GEX21 CFR 878.4810	Class II, GEX, 21 CFR878.4810	Class II, ONF, 21 CFR878.4810	Class II, ONF, 21 CFR878.4810
IntendedUse /Indicationsfor Use	The Venus Versa System isa multi-application deviceintended to be used inaesthetic and cosmeticprocedures.The SR515 and SR580 IPLapplicators are indicated forthe following:• Treatment of benignpigmented epidermal andcutaneous lesions including:hyperpigmentation,melasma, ephelides(freckles), lentigines, nevi,and cafe-au-lait macules.• Treatment of benigncutaneous vascular lesionsincluding port wine stains,hemangiomas, facial,truncal and legtelangiectasias, rosacea,angiomas and spiderangiomas, poikiloderma ofcivatte, leg veins andvenous malformations.	Ellipse I²PL System isintended for use indermatology:* Hair removal (permanenthair reduction).* Treatment of benignpigmented lesions (including,but not limited to solarlentigines, ephilides, mottledpigmentation) and benignvascular lesions (includingbut not limited to diffuseredness, telangiectasias, portwine stains).* Treatment of inflammatoryacne.[Table included in indicationsfor use form not includedhere, see Appendix 4 of510(k)]	The MATTIOLI PULSETWO/THREE PLUS is anIntense Pulse Light (IPL)device family indicated foruse in aesthetic applications(based on selectivephotothermolysis), in thetreatment of various benignpigmented lesions and hairremoval and that producedifferent effects dependingon the applicator that isused:SA APPLICATOR:Model SN: Wavelengthsfrom 560 - 1200 nm areindicated for treatment ofbenign pigmented (epidermaland cutaneous) lesions,including hyperpigmentation,warts, lentigines, nevi,melasma, and cafe-au-lait.VA APPLICATOR	The Platinum GMT™ IPLSystem Cloud device(inclusive of the hand pieceused to deliver pulsed-lightenergy) is indicated for usein surgical, aesthetic andcosmetic applications inpermanent hair reduction,moderate inflammatory acnevulgaris, benign cutaneouspigmented and vascularlesions.Permanent hair reduction isdefined as the long-termstable reduction in thenumber of hairs regrowingwhen measured at 6, 9, and12 months after thecompletion of a treatmentregimen.
MedicalDevice	Venus Concept Ltd.'sVenus Versa System –Full Configuration	Danish DermatologicDevelopment A/S EllipseI²PL System (K060516)	Mattioli Pulse TWO/THREEPlus Family (K100053)	Global Medical TechnologyS.L.'s Platinum GMT IPLSystem Cloud (K140668)
	The HR650, HR690,HR650XL, and HR690XLIPL applicators are indicatedfor the removal of unwantedhair and to effect stablelong-term or permanent hairreduction for skin types I-IV.Permanent hair reduction isdefined as the long-termstable reduction in thenumber of hairs regrowingwhen measured at 6, 9, and12 months after thecompletion of a treatmentregimen.The Venus ConceptACDUAL applicator isintended to be used for thetreatment of acne vulgaris.		Model VN: Wavelengthsfrom 510 - 1200 nm areindicated for the treatment ofbenign vascular lesionsincluding port wine stains,hemangiomas, facial, truncaland leg telangiectasias,rosacea, melasma,angiomas and spideranglormas, poikiloderma ofcivatte; leg veins, facial veinsand venous malformations.HR APPLICATORSindicated for the treatment ofunwanted hair (i.e. hairremoval).Model HN: Wavelengthsfrom 650-1200 nm for skintypes I-IV;Model HF: Wavelengths from710 - 1200 nm for skin typeVThe equipment should onlybe used under medicalsupervision.
Energy Type	IPL	IPL	IPL	IPL
IPLSpectrum	- Lesions: 515-950 nm(SR515); 580-950 nm(SR580)- Hair Removal: 650-950nm (HR650, HR650XL);690-950 nm (HR690,HR690XL)	400-950- Lesions:▪ Pigmented: 400-720 nm(PL)▪ Vascular: 555-950 nm(VL); 530-750 nm (PR)Hair Removal: 600-950nm	510-1200 nm- Lesions: 560-1200 nm(SA); 510-1200 nm (VA)- Hair Removal: 650-1200nm (HN); 710-1200 nm(HF)	430-1200 nm- Lesions: 560-1200 nm▪ Pigmented: 560-1200nm▪ Vascular: 560-1200 nm- Hair reduction: 695-1200
MedicalDevice	Venus Concept Ltd.'sVenus Versa System –Full Configuration	Danish DermatologicDevelopment A/S EllipseI²PL System (K060516)	Mattioli Pulse TWO/THREEPlus Family (K100053)	Global Medical TechnologyS.L.'s Platinum GMT IPLSystem Cloud (K140668)
- Acne: 415 - 480 nmand 630 - 950 nm(ACDUAL)		(HR, HR-S); 645-950 nm(HR-D)		nm- Acne: 430-1200 nm
Frequency	Up to 3 Hz (SR, HR, HR XL)Up to 2 Hz (ACDUAL)	1.5-2.0 s chargetime/repetition rate	Up to 1 Hz	1s, 2s, 3s repetitionfrequency
Spot Size	10 x 30 mm (SR 515, SR580, HR650, HR690,ACDUAL)20 x 30 mm (HR650XL,HR690XL)	10 x 48 mm	10 x 40 mm15 x 50 mm	10 x 45 mm8 x 34 mm
PulseDuration	5-20 ms (SR515, SR580,ACDUAL); 20-50 ms(HR650, HR690, HR650XL,HR690XL).	1.5-100 ms	14-35 ms	1-9.9 ms- Lesions:■ Pigmented: 3-9 ms▪ Vascular: 9.9 mso Hair reduction: 9.9 msAcne: 3-8 ms
EnergyDensity(Fluence)	Lesions/Acne (SR 515, SR580, ACDUAL):5-25 J/cm²Hair Removal (HR650,HR690, HR650XL,HR690XL): 5-20 J/cm²	Max 26 J/cm²- Lesions:■ Pigmented: up to 18J/cm²■ Vascular: up to 26 J/cm²Hair Removal: up to 21J/cm²	Max 30 J/cm²- Skin Rejuvenation (SR):6-30 J/cm²- Hair Removal (HR): 6-25J/cm²	Max 60 J/cm²- Lesions:■ Pigmented: 12-44 J/cm²▪ Vascular: 10-50 J/cm²- Hair reduction: 10-60J/cm²- Acne: 10-40 J/cm²
Components	System console (with userinterface)ApplicatorsUltrasonic gel	System console (with userinterface)ApplicatorsOptical coupling gel	System console (with userinterface)Applicators	System console (with userinterface)Applicators
Light guide	Sapphire light guide	Light guide	Crystal Light Guide	Sapphire light guide
Coolingsystem	Cooling system	Cooling system	Cooling system	Cooling system

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Substantial Equivalence Table #2 for Bipolar RF and PMF Applicators: (1) Diamondpolar; (2) Octipolar

Medical Device	Venus Concept Ltd.'sDiamondpolar and OctipolarApplicators	Venus Concept Ltd.'s Venus Legacy BXDevice (K142910)
Class, Product Code,Regulation	Class II, GEI, 21 CFR 878.4400	Class II, GEI, 21 CFR 878.4400
Intended Use / Indicationsfor Use	The Diamondpolar and Octipolarapplicators are non-invasive devicesintended for use in dermatologic andgeneral surgery procedures for femalesfor the non-invasive treatment ofmoderate to severe facial wrinkles andrhytides in Fitzpatrick skin types I-IV.	The device is a non-invasive deviceintended for use in dermatologic andgeneral surgery procedures for females forthe non-invasive treatment of moderate tosevere facial wrinkles and rhytides inFitzpatrick skin types I-IV
Energy Type	Bipolar RF, PMF	Bipolar RF, PMF
Applicators	DiamondpolarOctipolar	DiamondpolarOctipolar
Maximum RF Output Power	Diamondpolar: 75 WOctipolar: 150 W	Diamondpolar: 75 WOctipolar: 150 W
RF Output Frequency	1 MHz	1 MHz
Magnetic Pulse Frequency	15 Hz	15 Hz
Magnetic Field	Up to 15 Gauss	Up to 15 Gauss

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Substantial Equivalence Table #3 for Fractional RF Applicator: (1) Viva

Medical Device	Venus Concept Ltd.'sViva Applicator	Venus Concept Ltd.'s Viva SR Device(K150161)
Class, Product Code,Regulation	Class II, GEI, 21 CFR 878.4400	Class II, GEI, 21 CFR 878.4400
Intended Use / Indications forUse	The Viva applicator is intended fordermatological procedures requiringablation and resurfacing of the skin.	The Venus Viva SR System is intended fordermatological procedures requiring ablationand resurfacing of the skin.
Energy Type	Fractional RF	Fractional RF
(Maximum) RF Energy	62 mJ/pin	62 mJ/pin
Maximum RF Output Power	8 W	8 W
Applicator	Viva	Viva
Number of Pins	40 x 4 = 160 pins	40 x 4 = 160 pin
RF Output Frequency	0.46 MHz	0.46 MHz
Contact Area of Pin/ ActiveArea	133 mm²	133 mm²

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Performance Data and Standards

The performance of the Venus Versa has been demonstrated in testing. Electromagnetic Compatibility and Electrical Safety testing was conducted per AAMI/ANSI ES60601-1. IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-57. All results were passing. In addition, the patient contacting materials are biocompatible based on the established biocompatibility of the materials and per ISO 10993-5. The applicable cleaning, disinfection, and sterilization parameters have also been validated in testing.

The Venus Versa System also underwent software validation and results demonstrate that the software was appropriate for release.

System verification testing was performed on the subject Versa System with all 10 of the applicators. Results were all passing. Specifically, the Versa IPL applicators were tested to show that the measured fluence at each wavelength matches the expected value within the defined acceptance criterion. In addition, the light guide temperatures were also measured per the expected values. The measured fluence levels at each wavelength were within the expected values, demonstrating passing results for each applicator. Testing was conducted in increments of 5 J/cm² for a comprehensive evaluation across the range of fluence levels. The fluke measured temperatures of each applicator met specifications.

In addition, as previously submitted in K152790, the Venus Versa IPL applicators SR515, SR580, HR650, and HR690 were evaluated in spectrum testing. The Versa IPL applicators were measured using a spectrometer at each of the wavelengths. At each wavelength, the test results demonstrated that the spectral region is defined by the filter. Further, the ACDUAL applicator spectrum testing was also performed as part of the IEC 60601-2-57 testing.

For the Diamondpolar and Octipolar applicators, system verification testing showed that measured RF voltage, electromagnetic field density, and system temperature were within expected values and met the pass criteria. It should further be noted that the performance of these applicators were previously demonstrated in the company's cleared Legacy BX 510(k) (K142910).

For the Viva applicator, system verification testing showed that the measured output power (pulse width, pulse amplitude) was within expected values. In addition, the performance of the Viva applicator was previously demonstrated in the company's cleared Viva SR System 510(k) (K150161). As detailed in the report, system verification also ensured that the Versa applicators and system met technical and mechanical requirements. All results were passing.

Therefore, performance testing confirmed the equivalent technological characteristics and energy output available for the Versa compared to its predicate.

Substantial Equivalence

The Venus Versa has the same intended use and the same or similar indications for use, technological characteristics and principles of operation as its predicate devices. The technological differences between the Venus Versa and its predicates are minor, including

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some differences in terms of the spot size, frequency, and pulse duration. As detailed above, the minor technological differences between the Venus Versa and its predicate devices do not raise any new types of safety or effectiveness questions, given that the key energy parameters (i.e., wavelengths, fluence levels, total energy) are the same or similar for the devices. Therefore, the Venus Versa System presents similar technological characteristics as its predicates, in support of substantial equivalence.

Conclusions

The Venus Versa has the same intended use and the same or similar indications for use, technological characteristics and principles of operation as its predicate devices. Testing demonstrates that the device performs as intended for the indicated uses of each applicator. Minor differences between the subject and predicate devices do not present any new or different types of safety or effectiveness questions, as confirmed by device performance evaluations. In sum, the Venus Versa System is substantially equivalent to its predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.