· 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, 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 females for the non-invasive treatment of moderate to severe facial wrinkles in Fitzpatrick skin types I-IV.

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

Device Description

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

Intense Pulsed Light (IPL)
Magnetic Pulse (MP2)
Radiofrequency (RF)

AI/ML Overview

The provided document is a 510(k) summary for the Venus Versa PRO System. It outlines the device's technical characteristics and compares them to a predicate device and a reference device to demonstrate substantial equivalence. Crucially, this document explicitly states that no clinical studies were deemed necessary because the changes were minor and did not introduce new safety or effectiveness issues.

Therefore, I cannot provide details on acceptance criteria and a study proving the device meets them based on this document alone, as no such clinical study was performed or required for this 510(k) submission.

However, I can extract and summarize the information typically requested for such a description, framing it within the context of why certain elements (like performance metrics, sample sizes, expert adjudication, MRMC studies, and detailed ground truth establishment for a test set) are absent here.

Here's a breakdown of the requested information, explaining what is present in the document and what is not due to the nature of this 510(k) submission:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for Venus Versa PRO System (K232192)

Based on the provided 510(k) summary, the substantial equivalence determination for the Venus Versa PRO System was primarily based on technical equivalence to a predicate device (Venus Versa System, K153717) and a reference device (Venus Viva MD Device, K201164), rather than a new clinical performance study with defined acceptance criteria for a novel device or AI.

The document states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission." This indicates that the "acceptance criteria" were met by demonstrating that the Venus Versa PRO System did not introduce new safety or effectiveness concerns compared to its legally marketed predecessors and that its technical specifications were largely identical or within acceptable ranges.

1. Table of Acceptance Criteria and Reported Device Performance

Since no new clinical performance study was conducted for this 510(k) submission, there isn't a table of "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial for a novel device or an AI.

Instead, the "acceptance criteria" were implicit in demonstrating substantial equivalence through technical comparisons. The "reported device performance" is essentially the device's adherence to those technical specifications, which are identical or equivalent to the predicate devices.

Feature / Characteristic	Acceptance Criteria (from Predicate/Reference)	Reported Device Performance (Venus Versa PRO System)
Intended Use	Identical to Predicate/Reference	Identical
Regulation Class	Class II, ONF, GEX, GEI	Class II, ONF, GEX, GEI
Energy Type (IPL)	Identical to Predicate	Identical (IPL)
IPL Spectrum	Identical to Predicate	Identical (Lesions, Hair Removal, Acne spectra)
Frequency (IPL)	Identical to Predicate	Identical (Up to 3 Hz / Up to 2 Hz)
Spot Size (IPL)	Identical to Predicate	Identical (10x30mm, 20x30mm)
Pulse Duration (IPL)	Identical to Predicate	Identical (5-20ms, 20-50ms)
Energy Density (IPL)	Identical to Predicate	Identical (5-25 J/cm², 5-20 J/cm²)
Energy Type (RF/MP2)	Identical to Predicate	Identical (Bipolar RF, PMF)
Max RF Output Power (RF/MP2)	Identical to Predicate	Identical (Diamondpolar: 75W, Octipolar: 150W)
RF Output Frequency (RF/MP2)	Identical to Predicate	Identical (1 MHz)
Magnetic Pulse Frequency	Identical to Predicate	Identical (15 Hz)
Magnetic Field	Identical to Predicate	Identical (Up to 15 Gauss)
Energy Type (Fractional RF)	Identical to Predicate/Reference	Identical (Fractional RF)
Max RF Energy (Viva MD)	62 mJ/pin (160 pin tip)	62 mJ/pin (160 pin tip)
	124 mJ/pin (80 pin tip from Reference)	124 mJ/pin (80 pin tip)
Max RF Output Power (Viva MD)	Identical to Predicate/Reference	Identical (8W)
Energy Density (Viva MD)	Identical to Predicate/Reference	Identical (7.5 J/cm²)
Tip Number of Pins (Viva MD)	160 pins (from Predicate)	160 pins
	80 pins (from Reference)	80 pins
RF Output Frequency (Viva MD)	Identical to Predicate/Reference	Identical (0.46 MHz)
Electrical Safety (IEC 60601-1)	Compliance with standard	Confirmed compliance (changes did not affect results)
EMC (IEC 60601-1-2)	Compliance with standard	Confirmed compliance (changes did not affect results)
Bench Testing (80 pin tip)	Deliver same output power as predicate	Verified and passed
Software Verification & Validation	Function as intended	Performed and passed
Biocompatibility	Same product material as predicate	Confirmed same material

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable as no clinical test set was used for performance evaluation in this 510(k) due to the nature of the submission (demonstrating substantial equivalence through technical comparisons). Bench testing was conducted for the 80 pin tip.
Data Provenance: Not applicable for a clinical test set. The technical data is generated internally from Venus Concept Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical test set requiring expert ground truth was used for this 510(k). The regulatory decision was based on technical equivalence.

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

Not applicable as no clinical test set requiring adjudication was used for this 510(k).

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 a laser/light-based medical instrument for aesthetic procedures, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device is a hardware system, not a standalone algorithm.

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

Not applicable for a clinical performance study. The "ground truth" for this submission was the established safety and effectiveness of the legally marketed predicate and reference devices, as well as bench test results for the specific new feature (80-pin tip).

8. The sample size for the training set:

Not applicable. This document describes a medical device (laser/light system), not an AI/ML algorithm that requires a training set.

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

Not applicable. This document describes a medical device (laser/light system), not an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 11, 2023

Venus Concept Inc. % William Mcgrail SVP Technical Operations & Compliance Venus Concept USA Inc. 4001 SW 47th Ave. Suite 206 Davie, Florida 33314

Re: K232192

Trade/Device Name: Venus Versa PRO 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,GEI, GEX Dated: August 9, 2023 Received: August 10, 2023

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.

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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 medical devices and radiation-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.

MarkTrumbore -S	Digitally signed byMark Trumbore -SDate: 2023.09.1112:30:57 -04'00'
---------------------	---------------------------------------------------------------------------------

Mark Trumbore, 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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Indications for Use

510(k) Number (if known)

Device Name Venus Versa PRO System

Indications for Use (Describe)

The Venus Versa PRO 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:

· 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 MD applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

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)

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Image /page/3/Picture/0 description: The image shows the logo for Venus. The logo consists of a stylized letter V on the left and the word "VENUS" on the right. The letter V is made up of three curved lines that converge at the bottom. The word "VENUS" is in a sans-serif font and is all capitalized. The logo is black and white.

510(K) SUMMARY (As Required by 21.CFR.807.92)

1. SUBMITTER
Manufacturer:	Venus Concept, Inc.1800 Bering DriveSan Jose, CA 95112, USA
Contact Person:	William H. McGrailVice President, Global RA & QAVenus ConceptPhone: (978) 808-0420Email: bmcgrail@venusconcept.com
Date Prepared:	July 24, 2023

2. DEVICE INFORMATION

Trade/Device Name(s):	Venus Versa PRO System
Regulation Number:	21 CFR § 878.4810
Regulation Name:	Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulation Class:	Class II
Product Code:	ONF, GEX, GEI
Review Panel:	General & Plastic Surgery

3. PREDICATE DEVICES

	Device Name	510(k) Number
Predicate	Venus Versa System	K153717
Reference	Venus Viva MD Device	K201164

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Image /page/4/Picture/1 description: The image shows the logo for Venus. The logo consists of a stylized letter V on the left and the word "VENUS" on the right. The letter V is made up of three curved lines that converge at the bottom. The word "VENUS" is in a sans-serif font and is all capitalized.

4. INDICATIONS FOR USE

The Venus Versa PRO 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:

. 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, 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 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 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 rhytides in Fitzpatrick skin types I-IV.

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

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Image /page/5/Picture/1 description: The image contains the logo for Venus. The logo consists of a stylized letter V on the left and the word "VENUS" on the right. The letter V is made up of three curved lines that converge at the bottom, creating a sense of movement and flow. The word "VENUS" is written in a simple, sans-serif font, with all letters capitalized.

5. DEVICE DESCRIPTION

Intense Pulsed Light (IPL) ●
- 1. SR515
- 1. SR580
- 1. HR650
- 1. HR690
- 1. HR650XL
- 1. HR690XL
- 1. ACDUAL
Magnetic Pulse (MP2) ●
- 1. Diamondpolar
- 1. Octipolar
Radiofrequency (RF) ●
- 1. Viva MD (uses 80 and 160 disposable tips)

6. TECHNOLOGICAL CHARACTERISTICS

The Venus Versa PRO System has identical technological characteristics to its predicates. The Venus Versa PRO is a multi-application system that allows delivery of energy, similar to its predicates. The Versa PRO 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 PRO 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 and reference devices.

The technological differences between the Venus Versa PRO and its predicates are minor. An 80 pin tip, cleared in K201164 was added to the Viva applicator which increases the energy per pin to the skin and falls within the range of the predicate devices.

The technical differences between the Versa PRO and its predicates do not present any new or different issues of safety or effectiveness as the operation of the device and technological parameters are similar to those of the predicate. The Venus Versa PRO System presents similar technological characteristics as its predicates, in support of substantial equivalence. See Table 5-1 below.

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Image /page/6/Picture/1 description: The image shows the logo for Venus. The logo consists of a stylized letter V on the left and the word "VENUS" on the right. The letter V is made up of three curved lines that converge at the bottom. The word "VENUS" is in a sans-serif font and is all capitalized.

7. TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The Venus Versa PRO System is substantially similar in intended use to the predicate device Venus Versa System and has similar technological characteristics as the reference device Venus Viva MD System.

The Venus Versa PRO System contains all the same hardware and technological characteristics of the Venus Versa predicate device. The changes between the Versa PRO and Versa are summarized below:

1. Addition of an 80 pin tip for the Viva MD applicator cleared on the reference device.
1. Updated software to recognize the 80 pin tip.

Tables 5-1 through 5-3 compare the intended use, key performance and technological features of the Venus Versa PRO System with the predicate device.

The Venus Viva MD system was chosen as Reference device since it uses the exact Viva MD applicator and 80 pin tip that is being added to the Venus Versa System and for the same indications for use.

Table 5-1: Substantial Equivalence Comparison with Predicate Device for IPL Applicators: 1) SR515; 2) SR580; 3) HR650; 4) HR690; 5) HR650XL; 6) HR690XL; 7) ACDUAL

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Image /page/7/Picture/0 description: The image shows the word "VENUS" in a bold, sans-serif font. To the left of the word is a stylized letter "V" made up of three parallel lines that curve and converge at the bottom. The logo is simple and modern, with a focus on the brand name.

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Image /page/8/Picture/0 description: The image shows the word "VENUS" in a sans-serif font, with the letters spaced closely together. To the left of the word is a stylized "V" shape, composed of three parallel lines that curve and converge at the bottom. The logo is simple and modern, with a clean and minimalist design.

Table 5-2: Substantial Equivalence Comparison with Predicate Device for Bipolar RF and PMF Applicators: 1) Diamondpolar; 2) Octipolar

Product	Venus Versa PRO System (Subject)	Venus Versa System (Predicate)	Similarities and significant differences to the predicate device
Class, Product Code, Regulation	Class II, GEI, 21 CFR 878.4400	Class II, GEI, 21 CFR 878.4400	Identical
Intended Use / Indications for Use	The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.	The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.	Identical
Energy Type Applicators	Bipolar RF, PMFDiamondpolarOctipolar	Bipolar RF, PMFDiamondpolarOctipolar	Identical
Maximum RF Output Power	Diamondpolar: 75 WOctipolar: 150 W	Diamondpolar: 75 WOctipolar: 150 W	Identical
RF Output Frequency	1 MHz	1 MHz	Identical
Magnetic Pulse Frequency	15 Hz	15 Hz	Identical
Magnetic Field	Up to 15 Gauss	Up to 15 Gauss	Identical

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Image /page/9/Picture/1 description: The image shows the logo for Venus. The logo consists of a stylized letter V made up of three curved lines, followed by the word "VENUS" in a simple, sans-serif font. The logo is black and the background is white.

Table 5-3: Substantial Equivalence Comparison with Predicate and Reference Devices for Fractional RF Applicator: 1) Viva MD

Product	Venus Versa PROSystem(Subject)	Venus VersaSystem(Predicate)	Venus Viva MDSystem(Reference)	Similarities andsignificantdifferences tothe predicatedevice
Class, ProductCode, Regulation	Class II, GEI, 21 CFR878.4400	Class II, GEI, 21 CFR878.4400	Class II, GEI, 21 CFR878.4400	Identical
Intended Use /Indications forUse	The Viva MD applicatoris intended fordermatologicalprocedures requiringablation and resurfacingof the skin.	The Viva applicator isintended fordermatologicalprocedures requiringablation and resurfacingof the skin.	The Viva MDapplicator is intendedfor dermatologicalprocedures requiringablation and resurfacingof the skin.	Identical
Energy Type	Fractional RF	Fractional RF	Fractional RF	Identical
(Maximum) RFEnergy	62 mJ/pin - 160 pin tip124 mJ/pin - 80 pin tip	62 mJ/pin - 160 pin tip	62 mJ/pin - 160 pin tip124 mJ/pin - 80 pin tip	Different forPredicate.Same asReference.
Maximum RFOutput Power	8 W	8 W	8W	Identical
Energy Density	7.5 J/cm²	7.5 J/cm²	7.5 J/cm²	Identical
Applicator	Viva MD	Viva	Viva MD	Identical
Tip Number ofPins	- 40 x 4 = 160 pins- 40 x 2 = 80 pins	- 40 x 4 = 160 pins	- 40 x 4 = 160 pins- 40 x 2 = 80 pins	Different forPredicate.Same asReference.
RF OutputFrequency	0.46 MHz	0.46 MHz	0.46 MHz	Identical
Contact Area ofPin/ Active Area	133 mm²	133 mm²	133 mm²	Identical
Materials	- Plastic (Makrolon2458)- Stainless Steel tip pinelectrodes	- Plastic (Makrolon2458)- Stainless Steel tippin electrodes	- Plastic (Makrolon2458)- Stainless Steel tippin electrodes	Identical

SUBSTANTIAL EQUIVALENCY AND COMPARISON OF TECHNOLOGICAL SIMILARITIES & DIFFERENCES

As described in the comparison tables above, the Venus Versa PRO subject device has an identical intended use and indications for use, identical technological characteristics, and principles of operation as its predicate and reference devices. There are no technological differences between the Venus Versa PRO device and its predicate and reference devices, so there are no new issues of safety or effectiveness.

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Image /page/10/Picture/1 description: The image shows the logo for Venus. The logo consists of a stylized letter V on the left and the word "VENUS" on the right. The letter V is made up of three curved lines that converge at the bottom. The word "VENUS" is in a simple, sans-serif font.

The design and components in the Venus Versa PRO device, including the console and the applicators are identical to the design and components found in the predicate and the reference devices Venus Versa, K153717, (console and applicators) and Venus Viva MD, K201164 (viva applicator and 80 pin tip).

8. PERFORMANCE DATA

Summary of Non-Clinical Performance Testing 8.1

Electrical Safety: The added changes to the system do not affect the previous test results ● of IEC 60601-1 Medical electrical equipment, General requirements for Safety.
Electromagnetic Interference (EMC): The added changes to the system do not affect the ● previous test results for IEC 60601-1-2.
Bench Testing: A bench test was performed to verify that the 80 pin tip delivers the same output power as the predicate device.
Software: Software verification and validation testing has been performed and passed the . expected results. In all instances, the device functioned as intended and the results observed were as expected.
Biocompatibility: The 80 pin tip has the same product material as in the predicate device. ●

8.2 Clinical Performance Data

Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission.

9. CONCLUSION

The Venus Versa PRO System is as safe and effective as its predicate device, Venus Versa, cleared under K153717. The modified system has the same intended use and indications, similar technological characteristics, and similar principle of operation as its predicate device. The above discussed slight modifications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. Thus, the Venus Versa PRO System is substantially equivalent to its predicate.

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.

Product	Venus Versa PRO System(Subject)	Venus Versa System(Predicate)	Similarities andsignificantdifferences to thepredicate device
Class, ProductCode,Regulation	Class II, ONF, GEX,21 CFR 878.4810	Class II, ONF, GEX,21 CFR 878.4810	Identical
Indications forUse	The Venus Versa System is a multi-application device intended to beused in aesthetic and cosmeticprocedures.The SR515 and SR580 IPLapplicators are indicated for thefollowing:· Treatment of benign pigmentedepidermal and cutaneous lesionsincluding: hyperpigmentation,melasma, ephelides (freckles),lentigines, nevi, and cafe-au-laitmacules.	The Venus Versa System is a multi-application device intended to beused in aesthetic and cosmeticprocedures.The SR515 and SR580 IPLapplicators are indicated for thefollowing:· Treatment of benign pigmentedepidermal and cutaneous lesionsincluding: hyperpigmentation,melasma, ephelides (freckles),lentigines, nevi, and cafe-au-laitmacules.	Identical
Product	Venus Versa PRO System (Subject)	Venus Versa System (Predicate)	Similarities and significant differences to the predicate device
	• 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, 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 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.	• 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, 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 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.
Energy Type	IPL	IPL	Identical
IPL Spectrum	- Lesions: 515-950 nm (SR515); 580-950 nm (SR580)- Hair Removal: 650-950 nm (HR650, HR650XL); 690-950 nm (HR690, HR690XL)- Acne: 415 - 480 nm and 630 - 950 nm (ACDUAL)	- Lesions: 515-950 nm (SR515); 580-950 nm (SR580)- Hair Removal: 650-950 nm (HR650, HR650XL); 690-950 nm (HR690, HR690XL)- Acne: 415 - 480 nm and 630 - 950 nm (ACDUAL)	Identical
Frequency	Up to 3 Hz (SR, HR, HR XL)Up to 2 Hz (ACDUAL)	Up to 3 Hz (SR, HR, HR XL)Up to 2 Hz (ACDUAL)	Identical
Spot Size	10 x 30 mm (SR 515, SR 580, HR650, HR690, ACDUAL)20 x 30 mm (HR650XL, HR690XL)	10 x 30 mm (SR 515, SR 580, HR650, HR690, ACDUAL)20 x 30 mm (HR650XL, HR690XL)	Identical
Pulse Duration	5-20 ms (SR515, SR580, ACDUAL); 20-50 ms (HR650, HR690, HR650XL, HR690XL).	5-20 ms (SR515, SR580, ACDUAL); 20-50 ms (HR650, HR690, HR650XL, HR690XL).	Identical
Energy Density	Lesions/Acne (SR 515, SR 580, ACDUAL)	Lesions/Acne (SR 515, SR 580, ACDUAL)	Identical
Product	Venus Versa PRO System(Subject)	Venus Versa System(Predicate)	Similarities andsignificantdifferences to thepredicate device
	5-25 J/cm2	5-25 J/cm2
	Hair Removal (HR650, HR690,HR650XL, HR690XL): 5-20 J/cm2	Hair Removal (HR650, HR690,HR650XL, HR690XL): 5-20 J/cm2
Components	System console (with user interface)ApplicatorsUltrasonic gel	System console (with user interface)ApplicatorsUltrasonic gel	Identical
Light guide	Sapphire light guide	Sapphire light guide	Identical
Cooling system	Cooling system	Cooling system	Identical