Medical Diode Laser Systems (TR-B)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION November 28, 2025 Baoding Te'anzhou Electronic Technology Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, Hebei 200120 China Re: K252658 Trade/Device Name: Medical Diode Laser Systems (TR-B) 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 22, 2025 Received: August 22, 2025 Dear Boyle Wang: 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. {1} K252658 - Boyle Wang 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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} K252658 - Boyle Wang 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: 2025.11.28 13:57:09 -05'00' 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} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | 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) K252658 | | | Device Name Medical Diode Laser Systems (TR-B) | | | Indications for Use (Describe) The Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device’s 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device’s 1470nm laser is intended for: Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux. | | | 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." | | {4} 510(k) Summary K252658 # 510(k) Summary K252658 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. ## 1.0 Submitter's information Name: Baoding Te'anzhou Electronic Technology Co., Ltd. Address: Baoding Te'anzhou Electronic Technology Co., Ltd. Address: Room 1702, 17th Floor, Zhibo Technology Comprehensive Research And Development Building, No.89, Hengbin Road, Baoding, Hebei, China. Phone Number: +86-15631235764 Contact: Ms.Wenjia Shang Email: Ivan@tazlaser.com Date of Preparation: Nov.14, 2025 ## Prior submissions This is the first submission, there is no prior submission. ## Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 ## 2.0 Device information Trade name: Medical Diode Laser Systems Common name: Powered Laser Surgical Instrument Regulation name: Laser surgical instrument for use in general and plastic surgery and in dermatology Model(s): TR-B. ## 3.0 Classification Production code: GEX Regulation number: 21 CFR 878.4810 Classification: Class II Panel: General & Plastic Surgery ## 4.0 Predicate device information {5} 510(k) Summary K252658 # Predicate device 510(k) Number: K212734 Product Name: Diode laser therapy device Manufacturer: Triangel Rsd Limited # Reference device 1: 510(k) Number: K240179 Product Name: Medical Diode Laser (Model: L2) Manufacturer: Wuhan Pioon Technology Co., Ltd. # Reference device 2: 510(k) Number: K082721 Product Name: LaserPro 810, LaserPro 980 Manufacturer: PhotoMedex, Inc. # 5.0 Indication for Use Statement The Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for: Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux. # 6.0 Device description The Medical Diode Laser Systems generate a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coagulation of the target tissue. The Medical Diode Laser Systems generate a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Medical Laser Family has following characteristics: - Dual wavelengths - Temperature monitoring system Table 1 - Product Technical Specification | Laser type | GaAlAs diode laser | | --- | --- | | Device model | TR-B | | Wavelength | 980nm±20nm, 1470nm±20nm | {6} 510(k) Summary K252658 | Laser output power | 980±20nm cw 20W 1470nm±20nm cw 15W | | --- | --- | | Security level | Class I type B | | Laser output mode | Continuous, Pulse, Single. | | Pulse width | 0.1s-10s (stepping 0.1s) | | Cooling | Air Cooling | | Size | 310(L)*290(W)*205(H) mm | | Net weight | 7.45KG | | Fuse | F15AL250V | | Aiming beam | Diode laser of 650nm, power Max. 10mW, adjustable brightness. | | Beam divergence | 314 mrad to 443 mrad | | Application systems | Fiber core diameter: 400μm 600μm NA≥0.22 With SMA905 connector Before use must be sterilized | | Transmission system | Contact: fibers of 400μm or 600μm with SMA905 connector; Non-contact: fibers and tips | | Operation interface | Color LCD touch screen | | Power supply | 100-220VAC, 50/60Hz, 2.6-1.0A | | Waterproof level | IPX1 | | Footswitch Waterproof level | IPX8 | | Transportation & Storage environmental conditions | Temperature:-20°C~70°C, Relative humidity: 10%~90%, Atmospheric pressure: 80KPa~106KPa Without sensible vibration and shock | | Application environmental conditions | Temperature:10°C~40°C, Relative humidity: 10%~90%, Atmospheric pressure: 80KPa~106KPa | ## 7.0 Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - 60601-1-2 Edition 4.1 2020-09, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC 60601-2-22 Edition 4.0 2019-11, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - IEC 60825 Edition 2.0 2007-03, Part 1: Equipment classification and {7} 510(k) Summary K252658 requirements - IEC 60601-1-6 Edition 3.2 2020-07, Medical electrical equipment - Part 4-2: Guidance and interpretation - Guidance for the application of ISO 14971 - IEC 60601-4-2 Edition 1.0 2016-05, Guidance and interpretation- Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. - Software verification and validation testing were conducted and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff, “Content of Premarket Submissions for Device Software Function”. The recommended Documentation Level for software of this device was considered as a “Basic Documentation Level” and the documentation was provided accordingly. - Usability testing conducted. - Performance testing conducted to validate the output specifications of the device. ## 8.0 Clinical Test Conclusion No clinical study implemented for the Diode laser therapy device. ## 9.0 Technological Characteristic Comparison Table {8} 510(k) Summary K252658 Table 2 - General Comparison | Item | Proposed device | Predicated device | Reference device 1 | Reference device 2 | Remark | | --- | --- | --- | --- | --- | --- | | Product Code | GEX | GEX | GEX | GEX | Identical | | Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical | | Class | II | II | II | II | Identical | | Product name | Medical Diode Laser Systems | Diode laser therapy device | Medical Diode Laser | LaserPro 810, LaserPro 980 | - | | 510(k) No. | K252658 | K212734 | K240179 | K082721 | - | | Models | TR-B | ST-AR | L2 | - | - | | Indications for Use | The Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, | The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, | The Medical Diode Laser (Model: L2) is indicated for: -Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux | The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic(dermatology and plastic surgery), | Same | {9} 510(k) Summary K252658 Table 3 - Performance Comparison | Item | Proposed Device | Predicate Device | Reference device 1 | Reference device 2 | Remark | | --- | --- | --- | --- | --- | --- | | | Medical Diode Laser Systems | Diode laser therapy device | Medical Diode Laser | LaserPro 810, LaserPro 980 | | | | N/A | K212734 | K240179 | K082721 | | {10} 510(k) Summary K252658 | Wavelength | 980nm±20nm, 1470nm±20nm | 980nm±5nm, 1470nm±10nm | 1470 nm | 980 nm | * Gap 1 | | --- | --- | --- | --- | --- | --- | | Output Power max. | 20W/980nm±20nm, 15W/1470nm±20nm | 16W/980nm±20%, 4.5W/1470nm±20% | Up to 20W | 1-25W/980nm | * Gap 2 | | Aiming beam | Diode laser of 650nm, power Max. 10mW, adjustable brightness. | 650 nm, red 0.5 mW, user controlled intensity | Undisclosed data | 635-650nm, adjustable intensity | * Gap 3 | | Treatment mode | Continuous or Pulsed | Continuous or Pulsed | Continuous or Pulsed | Continuous or Pulsed | Same | | Power supply | 100-220VAC, 50/60Hz | AC110V±11V, 60HZ | 110/220 V | 100-240 VAC, 540VA max, 50/60Hz | * Gap 4 | | Interval | 980nm 1% ~ 100%, 1470nm 2% ~100%, continuously adjustable energy | 980nm 1% ~ 100%, 1470nm 2% ~100%, continuously adjustable energy | 1470nm 2% ~100%, continuously adjustable energy | 980nm 1% ~ 100%, continuously adjustable energy | Same | | Cooling system | Air cooled | Air cooled | Air cooled | Air cooled | Same | | Pulse duration range | 0.1 - 10 s | 0.05 ms - 1 s | 10 ms - 10 s | 0.05 s - 10 s | * Gap 5 | * Gap analysis: Gap 1: Both of the proposed device and predicate device have 980nm and 1470nm wavelength. The deviations of wavelength are similar, which does not create additional risk to the product use. Gap 2: The 980nm max power of the proposed device is close to the predicate device, which does not create additional risk to the product use. {11} 510(k) Summary K252658 For 1470nm max power of the proposed device is the same with reference devices, which does not create additional risks. Gap 3: The aiming beam of the devices are close, which difference does not create additional risks to the product clinical use. Gap 4: The power supply range of the proposed device is included in the predicate device and reference devices. Gap 5: The pulse duration range for subject device is 0.1 - 10 seconds, while the range for predicate device K212734 is 0.05 milliseconds - 1 second. For the difference of pulse duration range, we’ve decided to introduce reference devices. We have add the new reference devices K240179 and K082721. The pulse duration range for reference device K240179 is 10 ms - 10 s @1470nm. The pulse duration range for reference device K082721 is 0.05 s - 10 s @980nm. Both of the reference devices can comprehensively cover the pulse duration range for subject device. Therefore, this difference will not affect the safety and effectiveness. Table 4 - Safety Comparison | Item | Proposed Device | Predicate Device | Reference device 1 | Reference device 2 | Remark | | --- | --- | --- | --- | --- | --- | | | Medical Diode Laser Systems | Diode laser therapy device | Medical Diode Laser | LaserPro 810, LaserPro 980 | | | | Pending | K212734 | K240179 | K082721 | | | Electric safety | Comply with IEC 60601-1:2005+A1:2012+A2:2020, IEC 60825-1:2014, IEC 60601-2-22:2019 | Comply with IEC 60601-1:2005+A1:2012, IEC 60825-1:2014, IEC 60601-2-22:2007+A1:2012 | Comply with IEC 60601-1, IEC 60825-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60825-1, IEC 60601-2-22 | Same | | EMC | Comply with IEC 60601-1-2:2014+A1:2021 | Comply with IEC 60601-1-2:2014 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | {12} 510(k) Summary K252658 ## 10.0 Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Medical Diode Laser Systems is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K212734.