Venus Versa PRO System

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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. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about 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. | Mark<br>Trumbore -S | Digitally signed by<br>Mark Trumbore -S<br>Date: 2023.09.11<br>12:30:57 -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 {2}------------------------------------------------ ## 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. · 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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.<br>1800 Bering Drive<br>San Jose, CA 95112, USA | | Contact Person: | William H. McGrail<br>Vice President, Global RA & QA<br>Venus Concept<br>Phone: (978) 808-0420<br>Email: 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 | {4}------------------------------------------------ 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. {5}------------------------------------------------ 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 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) ● - 1) SR515 - 2) SR580 - 3) HR650 - 4) HR690 - 5) HR650XL - 6) HR690XL - 7) ACDUAL - Magnetic Pulse (MP2) ● - 1) Diamondpolar - 2) 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. {6}------------------------------------------------ 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. - 2. 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. | Product | Venus Versa PRO System<br>(Subject) | Venus Versa System<br>(Predicate) | Similarities and<br>significant<br>differences to the<br>predicate device | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | Class, Product<br>Code,<br>Regulation | Class II, ONF, GEX,<br>21 CFR 878.4810 | Class II, ONF, GEX,<br>21 CFR 878.4810 | Identical | | Indications for<br>Use | The Venus Versa System is a multi-<br>application device intended to be<br>used in aesthetic and cosmetic<br>procedures.<br>The SR515 and SR580 IPL<br>applicators are indicated for the<br>following:<br>· Treatment of benign pigmented<br>epidermal and cutaneous lesions<br>including: hyperpigmentation,<br>melasma, ephelides (freckles),<br>lentigines, nevi, and cafe-au-lait<br>macules. | The Venus Versa System is a multi-<br>application device intended to be<br>used in aesthetic and cosmetic<br>procedures.<br>The SR515 and SR580 IPL<br>applicators are indicated for the<br>following:<br>· Treatment of benign pigmented<br>epidermal and cutaneous lesions<br>including: hyperpigmentation,<br>melasma, ephelides (freckles),<br>lentigines, nevi, and cafe-au-lait<br>macules. | 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.<br>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.<br>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.<br>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.<br>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.<br>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.<br>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)<br>- Hair Removal: 650-950 nm (HR650, HR650XL); 690-950 nm (HR690, HR690XL)<br>- Acne: 415 - 480 nm and 630 - 950 nm (ACDUAL) | - Lesions: 515-950 nm (SR515); 580-950 nm (SR580)<br>- Hair Removal: 650-950 nm (HR650, HR650XL); 690-950 nm (HR690, HR690XL)<br>- Acne: 415 - 480 nm and 630 - 950 nm (ACDUAL) | Identical | | Frequency | Up to 3 Hz (SR, HR, HR XL)<br>Up to 2 Hz (ACDUAL) | Up to 3 Hz (SR, HR, HR XL)<br>Up to 2 Hz (ACDUAL) | Identical | | Spot Size | 10 x 30 mm (SR 515, SR 580, HR650, HR690, ACDUAL)<br>20 x 30 mm (HR650XL, HR690XL) | 10 x 30 mm (SR 515, SR 580, HR650, HR690, ACDUAL)<br>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<br>(Subject) | Venus Versa System<br>(Predicate) | Similarities and<br>significant<br>differences to the<br>predicate device | | | 5-25 J/cm2 | 5-25 J/cm2 | | | | Hair Removal (HR650, HR690,<br>HR650XL, HR690XL): 5-20 J/cm2 | Hair Removal (HR650, HR690,<br>HR650XL, HR690XL): 5-20 J/cm2 | | | Components | System console (with user interface)<br>Applicators<br>Ultrasonic gel | System console (with user interface)<br>Applicators<br>Ultrasonic gel | Identical | | Light guide | Sapphire light guide | Sapphire light guide | Identical | | Cooling system | Cooling system | Cooling system | Identical | 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 {7}------------------------------------------------ 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. {8}------------------------------------------------ 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, PMF<br>Diamondpolar<br>Octipolar | Bipolar RF, PMF<br>Diamondpolar<br>Octipolar | Identical | | Maximum RF Output Power | Diamondpolar: 75 W<br>Octipolar: 150 W | Diamondpolar: 75 W<br>Octipolar: 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 | {9}------------------------------------------------ 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 PRO<br>System<br>(Subject) | Venus Versa<br>System<br>(Predicate) | Venus Viva MD<br>System<br>(Reference) | Similarities and<br>significant<br>differences to<br>the predicate<br>device | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Class, Product<br>Code, Regulation | Class II, GEI, 21 CFR<br>878.4400 | Class II, GEI, 21 CFR<br>878.4400 | Class II, GEI, 21 CFR<br>878.4400 | Identical | | Intended Use /<br>Indications for<br>Use | The Viva MD applicator<br>is intended for<br>dermatological<br>procedures requiring<br>ablation and resurfacing<br>of the skin. | The Viva applicator is<br>intended for<br>dermatological<br>procedures requiring<br>ablation and resurfacing<br>of the skin. | The Viva MD<br>applicator is intended<br>for dermatological<br>procedures requiring<br>ablation and resurfacing<br>of the skin. | Identical | | Energy Type | Fractional RF | Fractional RF | Fractional RF | Identical | | (Maximum) RF<br>Energy | 62 mJ/pin - 160 pin tip<br>124 mJ/pin - 80 pin tip | 62 mJ/pin - 160 pin tip | 62 mJ/pin - 160 pin tip<br>124 mJ/pin - 80 pin tip | Different for<br>Predicate.<br>Same as<br>Reference. | | Maximum RF<br>Output 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 of<br>Pins | - 40 x 4 = 160 pins<br>- 40 x 2 = 80 pins | - 40 x 4 = 160 pins | - 40 x 4 = 160 pins<br>- 40 x 2 = 80 pins | Different for<br>Predicate.<br>Same as<br>Reference. | | RF Output<br>Frequency | 0.46 MHz | 0.46 MHz | 0.46 MHz | Identical | | Contact Area of<br>Pin/ Active Area | 133 mm² | 133 mm² | 133 mm² | Identical | | Materials | - Plastic (Makrolon<br>2458)<br>- Stainless Steel tip pin<br>electrodes | - Plastic (Makrolon<br>2458)<br>- Stainless Steel tip<br>pin electrodes | - Plastic (Makrolon<br>2458)<br>- Stainless Steel tip<br>pin 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. {10}------------------------------------------------ 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.