Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION August 28, 2026 Zhengzhou PZ Laser Slim Technology Co., Ltd. Junmei Li RA 3rd Floor, Bldg. 1, #101 Jinbai Rd., High-Tech Development Z Zhengzhou, Henan 450001 China Re: K261582 Trade/Device Name: Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) 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: NUV, ISA, PBX Dated: May 12, 2026 Received: May 13, 2026 Dear Junmei Li: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261582 - Junmei Li Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K261582 - Junmei Li Page 3 assistance/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, YAN FU-S Digitally signed by YAN FU - S Date: 2026.08.28 10:34:37 -04'00' for Tanisha Hithe 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K261582 Device Name Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) Indications for Use (Describe) The Vacuum Roller RF Slimming Device for Medical Use incorporates four therapeutic technologies: radiofrequency (RF), infrared (IR), vacuum, and mechanical roller massage. The device provides the following treatment modes: - Mode 1 - Massage & IR Therapy: Vacuum + IR + Roller Massage - Mode 2 - RF Massage Therapy: RF + Vacuum + Roller Massage - Mode 3 - Vacuum/IR Body Contouring: Vacuum + IR - Mode 4 - Massage Therapy: Vacuum + Roller Massage - Mode 5 - IR Massage Therapy: IR + Roller Massage The device is indicated for the following uses: - Modes 1, 2, 5 are indicated for the temporary relief of minor muscle aches and pain. - Modes 1, 2, 5 are indicated for the temporary relief of muscle spasm. - Modes 1, 2, 5 are indicated for the temporary improvement of local blood circulation. - Modes 1, 2, 3, 4 are indicated for the temporary reduction in the appearance of cellulite. - Modes 1, 3, 5 are indicated for the temporary reduction of thigh circumference. 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) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} 510(k)Summary # 510(k Summary K261582 This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K261582 # 1 Date of Preparation 08/26/2026 # 2 Sponsor Zhengzhou PZ Laser Slim Technology Co., Ltd. 3rd Floor, Building 1, No.101 Jinbai Road, High-tech Development Zone, 450001 Zhengzhou City, Henan Province, PEOPLE'S REPUBLIC OF CHINA Contact Person: Junmei Li Position: RA Tel: +86-18403935976 Email: 1055078817@qq.com # 3 Submission Correspondent Ms. Junmei Li Zhengzhou PZ Laser Slim Technology Co., Ltd. 3rd Floor, Building 1, No.101 Jinbai Road, High-tech Development Zone, 450001 Zhengzhou City, Henan Province, PEOPLE'S REPUBLIC OF CHINA Tel: +86-18403935976 Email: 1055078817@qq.com # 4 Identification of Subject Device Trade Name: Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) Common Name: Massager, Vacuum, Light induced heating Model(s): PZ-FY66-01, PZ-FY66-02 Regulatory Information: Classification Name: Massager, Vacuum, Light induced heating Classification: II Product Code: NUV, ISA,PBX 1/13 {5} 510(k)Summary Regulation Number: 21 CFR 878.4810 Review Panel: Physical Medicine, General & Plastic Surgery Intended Use: The Vacuum Roller RF Slimming Device for Medical Use is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences. Indication for Use: "The Vacuum Roller RF Slimming Device for Medical Use incorporates four therapeutic technologies: radiofrequency (RF), infrared (IR), vacuum, and mechanical roller massage. The device provides the following treatment modes: - Mode 1 - Massage & IR Therapy: Vacuum + IR + Roller Massage - Mode 2 - RF Massage Therapy: RF + Vacuum + Roller Massage - Mode 3 - Vacuum/IR Body Contouring: Vacuum + IR - Mode 4 - Massage Therapy: Vacuum + Roller Massage - Mode 5 - IR Massage Therapy: IR + Roller Massage The device is indicated for the following uses: - Modes 1, 2, 5 are indicated for the temporary relief of minor muscle aches and pain. - Modes 1, 2, 5 are indicated for the temporary relief of muscle spasm. - Modes 1, 2, 5 are indicated for the temporary improvement of local blood circulation. - Modes 1, 2, 3, 4 are indicated for the temporary reduction in the appearance of cellulite. - Modes 1, 3, 5 are indicated for the temporary reduction of thigh circumference." ### 5 Device Description The Vacuum Roller RF Slimming Device for Medical Use controls the RF power supply through the micro controller. After the channel is selected, the electrode is controlled by the treatment handle. Finally, it is applied to the human body. And data is exchanged between the micro controller and the treatment handle. The micro controller controls the gas path adjustment circuit. After the channel selection, infrared control, temperature control, roller control and treatment head recognition are completed through the treatment handle. Finally, it is applied to the human body. And data is exchanged between the micro controller and the treatment handle. 2/13 {6} 510(k)Summary  The system principle block is shown in Fig. 5-1.  Fig. 5-1 System principle block The model of the Vacuum Roller RF Slimming Device for Medical Use: PZ-FY66-01, PZ-FY66-02 The subject device includes the following components: Table 5-1 Main Components of Subject Device | Components | | Function Description | | --- | --- | --- | | Host | Power supply | 100-240V~ 50/60Hz | 3/13 {7} 510(k)Summary | | switching power supply | Convert the input voltage into the required output voltage to meet the needs of different electronic devices. | | --- | --- | --- | | | display screen | For human and machine interaction. | | Power cord | A connection tool that transfers electricity from a power source to an electrical device, allowing the device to function properly. | | | Treatment handle | Connect the host and the treatment head to realize the infrared control, temperature control, roller control and treatment head recognition function. | | | Treatment head | The electrical signal is converted into electrical energy to act on the patient. | | | Pendant | Suspended treatment handle. | | | Socket | Connect the main unit and treatment handle. | | | Caster | Installed at the bottom of the device to increase the mobility and flexibility of the device. | | | Main unit | Main unit includes RF power supply, switching power supply, control board and display screen. The switching power supply can convert the input voltage into the required output voltage to meet the needs of different electronic devices. | | | Key switch | Turn the device on/off. | | | EMG stop switch | Emergency stop device operation. | | | Fuse | Overload protection. | | | Power input sock | Connector for connecting the power cord to the device | | | Filter | Remove unwanted frequency components from a signal while retaining the desired frequency components. | | 4/13 {8} 510(k)Summary | DC contactor | Connect or disconnect the DC main circuit with load. | | --- | --- | ## 6 Identification of Predicate Device Predicate Device1 510(k) Number: K161892 Product Name: Slimming Treatment Device Manufacturer: Beijing Honkon Technologies Co., Ltd Predicate Device 2 510(k) Number: K122579 Product Name: VelaShape Manufacturer: Syneron Medical, Limited ## 7 Non-Clinical Test Conclusion Non-clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards: IEC 60601-1:2005+A1:2012+A2:2020, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance; IEC 60601-1-2:2014+A1:2020, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests; IEC 60601-2-2 : 2017+A1:2023Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories IEC TS 60601-4-2:2024 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems IEC 62304:2015, Medical device software – Software life cycle processes; ISO 14971:2019, Medical devices – Application of risk management to medical devices; ISO 10993-1:2020, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process; ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity; 5/13 {9} 510(k)Summary ISO 10993-10:2021, Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization; ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation; ### 8 Clinical Test Conclusion No clinical study is included in this submission. ### 9 Substantially Equivalent (SE) Comparison Table 9-1 General Comparison | Items | Subject Device K261582 | Predicate Device 1: K161892 | Predicate Device 2: K122579 | Analysis | | --- | --- | --- | --- | --- | | Manufacturer | Zhengzhou PZ Laser Slim Technology Co., Ltd. | Beijing Honkon Technologies Co., Ltd | Syneron Medical, Limited | N/A | | Regulation numbers | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | | Product Code | PBX, NUV, ISA | NUV, ISA | NUV | Analysis 1 | | Regulatory Class | Class II | Class II | Class II | Same | | Clinical Use | Prescription use | Prescription use | Prescription use | Same | | Intended use | The Vacuum Roller RF Slimming Device for Medical Use is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences. | The HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences. | The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences. | Same | | Indication For Use | "The Vacuum Roller RF Slimming Device for Medical Use incorporates four therapeutic technologies: | | | | 6/13 {10} 510(k)Summary | | radiofrequency (RF), infrared (IR), vacuum, and mechanical roller massage. The device provides the following treatment modes: • Mode 1 - Massage & IR Therapy: Vacuum + IR + Roller Massage • Mode 2 - RF Massage Therapy: RF + Vacuum + Roller Massage • Mode 3 - Vacuum/IR Body Contouring: Vacuum + IR • Mode 4 - Massage Therapy: Vacuum + Roller Massage • Mode 5 - IR Massage Therapy: IR + Roller Massage The device is indicated for the following uses: • Modes 1, 2, 5 are indicated for the temporary relief of minor muscle aches and pain. • Modes 1, 2, 5 are indicated for the temporary relief of muscle spasm. • Modes 1, 2, 5 are indicated for the temporary improvement of local blood circulation. • Modes 1, 2, 3, 4 are indicated for the temporary reduction in the appearance of cellulite. • Modes 1, 3, 5 are indicated for the temporary reduction of thigh circumference.” | | | | | --- | --- | --- | --- | --- | | Target Population | Adult Population which requires treatment as specified in the indication for | Adult Population which requires treatment as specified in the | Adult Population which requires treatment as specified in the indication | Same | 7/13 {11} 510(k)Summary | | use | indication for use | for use | | | --- | --- | --- | --- | --- | | Anatomical Sites | Body parts requiring treatment as specified in the indication for use | Body parts requiring treatment as specified in the indication for use | Body parts requiring treatment as specified in the indication for use | Same | # Analysis 1: Although the product code for the predicate device is not explicitly listed as including "PBX" in its publicly available 510(k) Summary, the predicate device actually incorporates the designs and functions associated with that code - specifically PBX (Massager, Vacuum, Radiofrequency-Induced Heat). Therefore, the subject device and the predicate device are equivalent in terms of technological characteristics and intended functionality. This difference will not affect the safety and efficacy of the subject device. 8/13 {12} 510(k)Summary Table 9-2 Performance Comparison | Items | Subject Device: K261582 | Predicate device 1: K161892 | Predicate Device 2 : K122579 | Analysis | | --- | --- | --- | --- | --- | | RF Output Energy | Up to 220W | 40-400W | Up to 150W | Analysis 1 | | RF Output Frequency | 1MHz | 1MHz | N.A | Same | | Max. RF output energy density | Large treatment head: 6.41W/cm² Adsorption treatment head: 10.01W/cm² Radio frequency treatment head: 9.29W/cm² | XF-I+: 12.14W/cm² XF-VII+: 27W/cm² | 115.38W/cm² 6.67W/cm² 12 W/cm² 9.38W/cm² | Analysis 2 | | Infrared energy | Large treatment handle: Max. 6W Medium treatment handle: Max. 4W | XF-I+ & XF-VII+: I: 5W II : 7W III : 8W IV : 9W V : 10W | Up to 3.3W | Analysis 3 | | Infrared wavelengths | 850nm | 700-2000nm | 850nm | Analysis 4 | | Max. IR output energy density | Large treatment handle: 0.17W/cm² Adsorption treatment head: 0.18W/cm² Radio frequency treatment head: 0.63W/cm² | XF-I+: 0.30W/cm² XF-VII+: 0.67W/cm² | 2.54W/cm² 0.44W/cm² 0.26W/cm² 0.21W/cm² | Analysis 5 | | Vacuum | Pulsed (Max.-80Kpa(-0.08Mpa)) | Pulsed (-0.08Mpa -0.01Mpa) | Pulsed | Analysis 6 | | Mechanical Massage | Yes | Yes | N.A. | Same | | Treatment Area | Large treatment head: 3433mm² | XF-I+: 3294 mm² | VContour Applicator: Small Cover Medium Cover | Analysis 7 | 9/13 {13} 510(k)Summary | | Adsorption head: 2198mm² Radio frequency treatment head: 634mm² Rollerball treatment handle: 32448mm² | XF-VII+: 1482mm² | Large Cover: 130 mm² 750 mm² 1250 mm² VSmooth Applicator: 1600 mm² | | | --- | --- | --- | --- | --- | | Weight | 60KG | 48KG | 20kg / 44lbs | Analysis 8 | | Size (mm) L*W*H | 809mm*809mm*1392mm | 434mm * 531mm *1354mm (Slimming I+) 531mm * 441mm *1716mm (Slimming III+) | 380* 490 *1320 | Analysis 9 | | Power supply | AC100V-240V; 50Hz/60Hz | 110V, 60HZ | 110VAC; 50Hz; | Analysis 10 | | Patient Contact Material | Handpiece Suction roller | Handpiece Suction roller | Handpiece Suction roller | Same | # Analysis 1: Compared with predicate device, although there is a difference but the reasons are as follows. Although there are differences in the "RF output energy" between the subject device and the predicate device, it was all tested and is compliant with IEC 60601-2-2. And the High "RF output energy" within the range of the predicate device's. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence. # Analysis 2: Compared with predicate device, although there is a difference but the reasons are as follows. Although there are differences in the "Max. RF output energy density" between the subject device and the predicate device. And the "Max. RF output energy density" within the range of the predicate device's. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence. # Analysis 3: Compared with predicate device, although there is a difference but the reasons are as follows. Although there are differences in the "Infrared energy" between the subject 10/13 {14} 510(k)Summary device and the predicate device. And the "Infrared energy" within the range of the predicate device's. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence. # Analysis 4: Compared with predicate device, although there is a difference but the reasons are as follows. Although the "Infrared wavelengths" of the subject device is different than in the predicate device, the "Infrared wavelengths" within the range of the predicate device's. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence. # Analysis 5: The subject device maximum IR output energy density ranges from a lower limit of 0.17 W/cm² to an upper limit of 0.63 W/cm². The upper limit of the subject device (0.63 W/cm²) falls within the range of the predicate device's upper limit, while the lower limit (0.17 W/cm²) is similar to that of predicate device 2 (0.21 W/cm²); the slight difference of 0.04 W/cm² falls within the margin of error(±20%) and does not impact the safety or effectiveness of the subject device. Therefore, the difference in maximum IR output energy density does not affect the safety or effectiveness of the subject device. # Analysis 6: Compared with predicate device, although there is a difference but the reasons are as follows. Although the "Vacuum" of the subject device is different than in the predicate device, the high "Vacuum" within the range of the predicate device's. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence. # Analysis 7: The lower and upper limits for the IR Treatment Area of the subject device are 634mm² and 3433mm², respectively. The upper limit of the subject device (3433 mm²) is similar to that of predicate device 1, and the lower limit (634 mm²) falls within the range of predicate device 2. Therefore, the differences in IR Treatment Area do not affect the safety and effectiveness of the subject device. # Analysis 8: Not identical. That difference does not generate a safety and effectiveness issue. # Analysis 9: Not identical. That difference does not generate a safety and effectiveness issue. # Analysis 10: Not identical. The subject device provides a different "Power supply" than the predicate device. Electrical safety testing and EMC testing have been performed for the subject device. Risk analysis have also been performed to support proof of safety 11/13 {15} 510(k)Summary and effectiveness of the subject device. This difference does not raise new questions of safety and effectiveness compared to the predicate devices. 12/13 {16} 510(k)Summary Table 9-3 Safety Comparison | Item | Subject Device | Predicate Device1,2 | Remark | | --- | --- | --- | --- | | Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE | | | Comply with IEC TS 60601-4-2 | / | | | RF Safety | Comply with IEC 60601-2-2 | Comply with IEC 60601-2-2 | SE | | Biocompatibility | No toxicity (ISO 10993-5) | Cytotoxicity No toxicity (ISO 10993-5) | SE | | | Applied sample did not induce irritation to skin. (ISO 10993-10) | Irritation Applied sample did not induce irritation to skin. (ISO 10993-10) | SE | | | The test article showed no signification evidence of causing skin sensitization in the New Zealand white rabbits. (ISO 10993-23) | Sensitization The test article showed no signification evidence of causing skin sensitization in the guinea pig. (ISO 10993-10) | SE | # Analysis The subject device is substantially equivalent to the predicate devices. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices. # 10 Substantially Equivalency Conclusion Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate devices K161892 and K122579. 13/13