Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 17, 2026 Zhengzhou PZ Laser Slim Technology Co., Ltd. Xinye Li Official Applicant 3rd Floor, Bldg. 1, #101 Jinbai Rd. High-Tech Development Zone Zhengzhou, Henan 450001 China Re: K261817 Trade/Device Name: Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) 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: GEX Dated: August 18, 2026 Received: August 18, 2026 Dear Xinye 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} K261817 - Xinye 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. {2} K261817 - Xinye Li Page 3 See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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, TANISHA L. HITHE -S Digitally signed by TANISHA L. HITHE -S Date: 2026.09.17 14:45:53 -04'00' 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} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261817 | ? | | Please provide the device trade name(s). | | ? | | Diode Laser Therapy System | | | | Please provide your Indications for Use below. | | ? | | The Diode Laser Therapy System is intended for use in dermatological procedures requiring coagulation. The indications for use include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The HR Mode is intended for use in dermatological procedures requiring coagulation. The indications for use for the HR Mode include: Benign vascular and vascular dependent lesions. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} 510(k) Summary The assigned 510(k) Number: K261817 ## **510(k)Summary** This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92. 1. Date of preparation:May 30,2026 2. Sponsor Identification: **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: Xiaojie Shi Position: RA Tel: +86-18703657355 Fax: +86-0371-55677886 Email: shixiaojie1225@163.com 3. Designated Submission Correspondent **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: Xinye Li Tel: +86-18652732821 Fax: +86-0371-55677886 Email: 316863169@qq.com 1 / 9 {5} 510(k) Summary--- #### 4. Identification of Proposed Device Trade Name: Diode Laser Therapy System Models: PZ-BDT67-01, PZ-BDT67-02 Common Name: Powered Laser Surgical Instrument #### Regulatory Information Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Review Panel: General & Plastic Surgery #### Intended Use: The Diode Laser Therapy System is intended for use in dermatological procedures requiring coagulation. The indications for use include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The HR Mode is intended for use in dermatological procedures requiring coagulation. The indications for use for the HR Mode include: Benign vascular and vascular dependent lesions. #### 5. Device Description: The Diode Laser Therapy System is mainly composed of one host, treatment handle, power cord and treatment head. The host includes laser power supply, water circulation cooling system, control board and display screen. There are two models included, PZ-BDT67-01 and PZ-BDT67-02, the two models have the same intended use, mechanism of action and principle. The difference only lies in the step length for adjusting energy density on the instrument interface. The detailed difference shown 2 / 9 {6} 510(k) Summary as following: Table 1 The difference of Models | Item | PZ-BDT67-01 | PZ-BDT67-02 | | --- | --- | --- | | Energy density | Step size: 1J/cm\( ^{2} \) | Step size:2J/cm\( ^{2} \) | ## 6. Identification of Predicated Device 510(k) Number: K251329 Trade/Device Name: Diode laser device (RF3120-BI) Manufacturer: RiSu Medical Technology Co., Ltd. Identification of Reference Device 510(k) Number: K222064 Trade/Device Name: The Alma Soprano Titanium Manufacturer: Alma Lasers Inc. ## 7. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed 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 - Requirements and tests; 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 60601-2-22:2019, Medical electrical equipment - Part 2-22: Particular requirements 3 / 9 {7} 510(k) Summary for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment ➤ IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements ➤ ISO 10993-5:2009, Biological Evaluation of Medical Devices, Part 5-Tests for in vitro cytotoxicity ➤ ISO 10993-10:2021, Biological Evaluation of Medical Devices, Part 10-Tests for 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. 4 / 9 {8} 510(k) Summary # 9. Substantially Equivalent (SE) Comparison Table 2 General Comparison | Item | Proposed Device | Predicate Device K251329 | Reference Device K222064 | | --- | --- | --- | --- | | Device Name | Diode Laser Therapy System | Diode laser device (Trio- Wavelength Handpiece) | Soprano Titanium (Soprano Trio diode laser module) | | Model | PZ-BDT67-01, PZ-BDT67-02 | RF3120-BI | / | | Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | | Regulation Medical Specialty | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | | Device Class | II | II | II | | Product Code | GEX | GEX | GEX | | Intended Use | The Diode Laser Therapy System is intended for use in dermatological procedures requiring coagulation. The indications for use include: The Super Hair Removal (SHR) Mode and SHR Stack Mode are intended for temporary hair reduction. The HR Mode is intended for use in dermatological | The Diode laser device is intended for use in dermatology procedures requiring coagulation. The indications for use for the Trio-Wavelength Handpiece include: The Fast Hair Removal (FHR) Mode is intended for temporary hair reduction. The HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the | The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Soprano Trio diode laser module HR mode is intended for use in | 5 / 9 {9} 510(k) Summary | | procedures requiring coagulation. The indications for use for the HR Mode include: Benign vascular and vascular dependent lesions. | HR mode include: Benign vascular and vascular dependent lesions. | dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions. | | --- | --- | --- | --- | | Configuration | Main Unit | Main unit | Main Unit | | | Handpiece | Handpiece | Handpiece | | | Foot switch | Foot pedal | Foot control | Table 3 Performance Comparison | Item | Proposed Device | | Predicate Device K251329 | | Reference Device K222064 | | | --- | --- | --- | --- | --- | --- | --- | | Laser Type | Diode Laser | | Diode Laser | | Diode Laser | | | Laser Classification | Class IV | | Class IV | | Class IV | | | Laser Wavelength | 755+808+1064nm | | 755&808&1064 nm | | Trio-wavelength 755+810+1064nm | | | Laser Module Power | 1000W | | NA | | 600W/800W/1000W/1200W/1600W | | | Handpiece tip material | Sapphire | | Gemstone Crystals | | Sapphire | | | Spot Size | 12*19mm | | 12*20mm | | 4cm² | | | Energy Density (J/cm²) | SHR | 3-8 | FHR | 2-8 | SHR | 1-8 | | | HR | 3-60 | HR | 2-60 | HR | 2-120 | | Frequency | 1Hz-10Hz | | 1Hz-10Hz | | Up to 10Hz | | 6 / 9 {10} 510(k) Summary | Pulse Duration | 7-183ms | 5-200ms | Up to 200 ms | | --- | --- | --- | --- | | Power Supply | AC100-240V;50Hz/60Hz | AC100V-240V,50Hz/60Hz | 230 VAC, 16A, 50/60 Hz | | Dimension | 620mm*400mm*450mm | 375mm*440mm*1170mm | 120 cm * 39 cm * 38 cm, | | Weight | 39kg | 52kg | 84kg | #### Analysis: The proposed device shares the same intended use, laser type, laser wavelength and pulse frequency as the predicate device (K251329), with substantially consistent spot size and energy density. #### Laser Module Power The laser module power of the proposed device is the same as one of the laser module power configurations of the reference device (K222064). Its energy density is also within the parameter range of the reference device (K222064), which evidences that variations in laser module power will not raise new safety concerns for the proposed device. Meanwhile, effectiveness is directly correlated with energy density. #### Spot Size and Energy Density The spot size of the proposed device and the Predicate Device(K251329) is nearly identical, and the energy density for their corresponding modes is also substantially equivalent. #### Pulse Duration For the difference on pulse duration between the predicate (K251329) and proposed device, we can see that the pulse duration range of proposed device is within the range of the predicate device. There is only a minor difference in pulse duration between the proposed device and the predicate device. And this minor difference will not affect the effectiveness 7/9 {11} 510(k) Summary and safety. ## Dimension and Weight The proposed device is different in dimension and weight from the predicate device and the reference device. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted, therefore, this difference of dimension and weight has no effect on safety and effectiveness. Table 4 Safety Comparison | Item | Proposed Device | Predicate DeviceK251329 | Reference DeviceK222064 | | --- | --- | --- | --- | | EMC, Electrical and Laser Safety | | | | | Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | | Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | | Patient Contact Materials and Biocompatibility | | | | | Cytotoxicity | Comply with ISO 10993-5 | Comply with ISO 10993-5 | Comply with ISO 10993-1 | | Sensitization | Comply with ISO 10993-10 | Comply with ISO 10993-10 | | | Irritation | Comply with ISO 10993-23 | Comply with ISO 10993-23 | | ## 10. Substantially Equivalent (SE) Conclusion 8 / 9 {12} 510(k) Summary Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device (K251329). 9 / 9