1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION September 2, 2026 Zhengzhou PZ Laser Slim Technology Co., Ltd. Yueming Li Regulatory Affairs Specialist 3rd Floor, Bldg. 1, # 101 Jinbai Rd., High-Tech Development Zone, 450001 Zhengzhou, China Re: K261589 Trade/Device Name: 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) 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: July 31, 2026 Received: July 31, 2026 Dear Yueming 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} K261589 - Yueming 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} K261589 - Yueming 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, TANISHA Digitally signed by TANISHA L. HITHE -S L. HITHE -S Date: 2026.09.02 14:12:00 -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} 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) K261589 Device Name 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) Indications for Use (Describe) 1927nm Thulium Laser system is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles). 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 The assigned 510(k) Number: K261589 ## 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. **1. Date of preparation:** 08/24/2026 **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: Shi Xiaojie Position: RA Tel:+86-18703657355 Fax:+86-371-55677886 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: Li Yueming Tel:+86-18860362551 Fax:+86-371-55677886 Email: boluobao1010@qq.com **4. Identification of Proposed Device** Trade Name: 1927nm Thulium Laser System Models: PZ-DJG85-01, PZ-DJG85-02 Common Name: Powered Laser Surgical Instrument Regulatory Information Classification Name: Powered Laser Surgical Instrument Classification: II 1 / 5 {5} 510(k) Summary 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: 1927nm thulium laser system is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos(age spots), solar lentigos (sun spots)and ephelides (freckles). ### 5. Device Description 1927nm Thulium Laser System contains a thulium-doped fiber laser module that uses a 1927nm pulsed laser output energy. The beam is directly irradiated to the treatment area through the handle and optical fiber. According to the selective light absorption theory, the 1927nm laser can be preferentially absorbed by the water in the skin, thus achieving the purpose of coagulation of soft tissue. The operator can optimize the treatment effect of each application by controlling the pulse width, distance between the dot matrices and treatment mode of the pulsed laser. There are 2 models included, PZ-DJG85-01, PZ-DJG85-02, the two models have the same intended use, mechanism of action and principle, only the step of pulse width under the dot matrix mode are different. ### 6. Identification of Predicate Device 510(k) Number: K252732 Product Name: 1927nm Thulium Laser System(PZ-DJG75-01, PZ-DJG75-02) Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd ### 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. 2 / 5 {6} 510(k) Summary IEC 60601-1:2020 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance. IEC 60601-2-22:2019, Medical Electrical Equipment - Part 2-22: Particular Requirements 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. IEC 60601-1-2:2020, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic disturbances- Requirements and tests. 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. Performance Testing for Spot Size Accuracy and Energy Output Accuracy. ## 8. Clinical Test Conclusion No clinical study is included in this submission. ## 9. Substantially Equivalent (SE) Comparison Table 1 General Comparison | Item | Proposed Device | Predicate Device | | --- | --- | --- | | Device Name | 1927nm Thulium Laser System | 1927nm Thulium Laser System | | Classification regulation | 21CFR 878.4810 | 21CFR 878.4810 | | Classification Panel | General & Plastic Surgery | General & Plastic Surgery | | Class | II | II | | Product Code | GEX | GEX | 3 / 5 {7} 510(k) Summary | Common name | Powered laser surgical instrument | Powered laser surgical instrument | | --- | --- | --- | | Indication for use | 1927nm thulium laser system is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles). | 1927nm thulium laser system is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles). | | Prescription use or not | Prescription use | Prescription use | Table 2 Performance comparison | Item | Proposed device | Predicate device | | --- | --- | --- | | Laser Type | Thulium laser | Thulium laser | | Laser Wavelength | 1927nm | 1927nm | | Aiming Beam | 658nm, <5mW | 658nm,<5mW | | Beam delivery | Fiber and Handpiece | Fiber and Handpiece | | Emission control | Foot Switch | Foot Switch | | Maximum Pulse energy | 20mJ | 20mJ | | Pulse Width | 0.2-20ms | 0.2-20ms | Table 3 Safety Comparison | Item | Proposed Device | Predicate Device | | --- | --- | --- | | Patient Contact Materials and Biocompatibility | | | | Cytotoxicity | No Cytotoxicity | No Cytotoxicity | | Sensitization | No evidence of sensitization | No evidence of sensitization | | Irritation | No evidence of irritation | No evidence of irritation | | EMC, Electrical and Laser Safety | | | 4 / 5 {8} 510(k) Summary | Electrical Safety | 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 | | Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | Indication for use: the indication for use of the proposed device is the same as the predicate device. Technology: the proposed device utilizes the same technology as the predicates. Material: the handle tip of the proposed device that contact patients are the same to the handle tip of the predicate device, so the contact parts of the predicate device comply with ISO 10993. ### 10. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device. 5 / 5