← Product Code [GEX](/productcode/GEX) · K262349 # Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI) (K262349) _Risu Medical Technology Co., Ltd. · GEX · Oct 27, 2026 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K262349 ## Device Facts - **Applicant:** Risu Medical Technology Co., Ltd. - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** Oct 27, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Diode laser device is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Diode laser device is further indicated for laser assisted lipolysis. Diode Laser in low level laser therapy: Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. ## Device Story Diode laser system (models DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI) for surgical soft tissue procedures and LLLT. Inputs: user-defined parameters via 10.4-inch touch display. Operation: microprocessor-controlled diode laser source (980 nm/1470 nm for surgery; 650 nm for LLLT/aiming). Output: continuous or pulsed infrared laser energy delivered via optical fiber. Used in clinical settings by medical specialists. Foot switch controls laser emission. TEC and air cooling manage thermal output. Output affects tissue via thermal vaporization, incision, or coagulation; LLLT output provides temporary pain relief and circulation increase. System includes main unit, power cord, foot switch, and protective eyewear. ## Clinical Evidence No clinical data included. Bench testing only. Device performance verified against IEC 60601-1, IEC 60825-1, IEC 60601-2-22, and IEC 60601-1-2. Bench tests included appearance, wavelength, output power stability, pulse width/interval, aiming beam, and software functions. ## Technological Characteristics Diode laser system; 980nm/1470nm surgical wavelengths; 650nm aiming/LLLT wavelength. Class IV laser. TEC and air cooling. 10.4-inch capacitive touch interface. Microprocessor-controlled. Optical fiber delivery. Power: 100-240VAC, 50/60Hz. Dimensions: 343x230x318 mm; 10kg. Software: Basic Documentation Level. ## Regulatory Identification (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. ## Predicate Devices - Medical Diode Laser (M2-GK) ([K240747](/device/K240747.md)) - SkyPulse ([K193656](/device/K193656.md)) ## Reference Devices - D-Laser Blue ([K210367](/device/K210367.md)) - D-Laser 16 ([K210367](/device/K210367.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {1} **FDA** U.S. FOOD & DRUG ADMINISTRATION October 27, 2026 Risu Medical Technology Co., Ltd. % Owen He Consulant Microkn Medical Technology Service (Shanghai) Co., Ltd. Rm. 901, Huafa Center, 889 Pinglu Rd., Jing 'An District Shanghai, Shanghai 200040 China Re: K262349 Trade/Device Name: Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI) 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: September 28, 2026 Received: September 28, 2026 Dear Owen He: 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 {2} K262349 - Owen He Page 2 Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. 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 {3} K262349 - Owen He Page 3 Office of Industry and Consumer Education (OICE) to ask a question about a specific regulatory topic. See the OICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-office-industry-and-consumer-education-oice) for more information or contact OICE by email (AskOICE@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: 2026.10.27 16:14:36 -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 {4} 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) K262349 Device Name Diode laser device(DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI) Indications for Use (Describe) The Diode laser device is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Diode laser device is further indicated for laser assisted lipolysis. Diode Laser in low level laser therapy: Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. 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 {5} # 510(k) Summary ## 1. Contact information ### 1.1. Applicant Applicant Name: Risu Medical Technology Co., Ltd. Address: Rm 201, Bldg 11, Western Cloud Valley(Phase III), the intersection of Kangding Road and Tongwen Road, Fengxi New City of Xixian New Area, Shaanxi Province, China. Xian Shaanxi 712000 China Contact Person: Mr. Fuyan Yang Tel: +86-18515505758 Email: yangfuyan@risumed.com Date prepared: Oct. 27. 2026 ### 1.2. Consultant Company: Microkn Medical Technology Service (Shanghai) Co.,Ltd. Address: Room 901, No. 889, Pinglu Road, Jing'an District, Shanghai (Shanghai Jing'an HUAFA Center) Contact Person: Mr. Owen He Telephone: +86 13524136210 Email: fda@microkn.com {6} ## 2. Device information - Trade Name: Diode laser device - Model(s): DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI - Classification: II - Product Code: GEX - Regulation Number: 21 CFR 878.4810 ## 3. Indications for Use The Diode laser device is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Diode laser device is further indicated for laser assisted lipolysis. Diode Laser in low level laser therapy: Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood {7} circulation and/or temporary relaxation of muscles. #### **4. Legally Marketed Predicate Device** - ❖ Predicate Device 1 - ● Trade/Device Name: Medical Diode Laser (M2-GK) - ● 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 - ● 510k number: K240747 - ❖ Predicate Device 2 - ● Trade/Device Name: SkyPulse - ● 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 - ● 510k number: K193656 - ❖ Reference Device - ● Trade/Device Name: D-Laser Blue, D-Laser 16 - ● 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 {8} - Product Code: GEX - 510k number: K210367 ## 5. Description of the device This medical device utilizes a Diode Laser to achieve therapeutic functions and can output continuous or pulsed infrared laser with nominal wavelengths of 980 nm and 1470 nm. The device is equipped with a 650 nm red indicator semiconductor tube for positioning and marking the laser irradiation area. The product consists of a main unit, power cord, foot switch, and protective glasses. The power cord connects the main unit to the mains power supply, providing the necessary electrical energy for operation. The main unit contains a power supply device, a control device, and a Diode Laser light source. The power supply device distributes electrical energy to each component. The control device (including a 10.4-inch touch display screen and a control board) sends control signals to the control board by adjusting user interface parameters, thereby controlling and adjusting the laser output energy and frequency. The Diode Laser light source is responsible for emitting the laser, and its emission on/off is controlled by the foot switch. The protective glasses are used to protect the operator's eyes during operation. ## 6. Non-Clinical Test ### 6.1 Safety and Performance test The proposed device has been tested according to the following standards for basic safety, laser safety, and essential performance: IEC 60601-1:2005+A1:2012+A2:2020 – Medical electrical equipment – Part 1: {9} General requirements for basic safety and essential performance IEC 60825-1:2014 – Safety of laser products – Part 1: Equipment classification and requirements 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 The safety and performance of the device meet the applicable requirements of the above standards. #### 6.2 EMC test The proposed device has been tested according to the following electromagnetic compatibility standards: 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 TR 60601-4-2:2016 – Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems The EMC properties of the device meet the applicable requirements #### 6.3 Bench test The proposed device has been tested according to the following items: Appearance Requirements, Laser Wavelength, Laser Terminal Output Power, Laser Output Power Instability, Reproducibility of Laser Output Power, Laser Pulse Width, Laser Pulse Interval, Aiming Beam, Software Functions #### 6.4 Software test Software verification and validation testing were conducted and documentation was {10} 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 ## 7. Clinical Test Conclusion No clinical study is included in this submission. {11} ## 8. Substantially Equivalent (SE) Comparison The Diode laser device has been carefully compared to the legally marketed predicate devices with General comparison (Table 1: vs. K240747 for 980nm and 1470nm wavelengths), and General comparison (Table 2: vs. K193656 and K210367 for 650nm wavelength). Table 1 General comparison | Item | Proposed Device (K262349) | Predicated device 1 (K240747) | Remark | | --- | --- | --- | --- | | Product Code | GEX | GEX | SE | | Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE | | Class | II | II | SE | | Indication for use | The Diode laser device is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, | The Medical Diode Laser(Model: M2-GK) is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, | SE | {12} | | Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology,Head/ neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Diode laser device is further indicated for laser assisted lipolysis. | Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: M2-GK) is further indicated for laser assisted lipolysis. | | | --- | --- | --- | --- | | Use of Device | Rx only | Rx only | SE | | Laser Type | Diode laser | Diode laser | SE | | Laser Classification | Class IV | Class IV | SE | | Configuration | Main Unit | Main Unit | SE | | | Foot Control | Foot Control | | | Wavelength | 980nm 1470nm | 980nm 1470nm | SE | | Max Power | 980nm-30W | 980nm-30W | SE | {13} | | 1470nm-15W | 1470nm-15W | | | --- | --- | --- | --- | | Operation Mode | CW, QCW | CW, single pulse, repeat pulse | Note1 | | Pulse Duration | 10ms – 1s | 10 ms – 1s | SE | | Repetition Rate | 0.5 to 50 Hz | 0.5 to 50 Hz | SE | | Aiming Beam | 650nm, <2mW | Red 650nm (<2mW) | SE | | Cooling Method | TEC + Air Cooling | Air cooling | Note 2 | | Delivery System | Optical Fiber Output | Fiber delivery | SE | | User Interface | LCD capacitive touch screen | Color LCD touch screen | SE | | Microprocess or Control | Yes | Yes | SE | | Power Supply | AC100-240V, 50/60Hz, 500VA | 100-240VAC, 50/60Hz, 4A-2A | Note 3 | | Dimensions &Weight | 343×230×318 mm (L×W×H); 10kg | 29cm (L) x 25cm (W) x13cm (H) ≤8 Kg. | Note 4 | {14} Table 2 General comparison | Item | Proposed Device (K262349) 650nm Low level laser therapy | Predicated device 2 (K193656) 670nm Low level laser therapy | Reference Device (K210367) 650nm Low level laser therapy | Remark | | --- | --- | --- | --- | --- | | Indication for use | Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. | Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. | Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. | SE | | Energy source | Solid state diode | Solid state diode | Solid state diode | SE | | Wavelength | 650nm | 670 nm | 650 | Note 5 | | Power range | 0.1 – 0.2W | 0.1-4 W | 25mW-200 mW; CW | Note 6 | | Pulse width | 10ms-1s; CW | 10ms-10s; CW | / | Note 7 | | Repetition rate | 0.5 to 50 Hz | up to 100 Hz | 1 Hz - 20kHz | Note 8 | 4 {15} | | | | | | | --- | --- | --- | --- | --- | | Delivery system | Optical Fiber Output | Fiber delivery | Optical Fiber Output | SE | | User interface | Touch screen control | Touch screen control | Touch screen control | SE | ### Note 1: The subject device offers CW and QCW (understood as repeat mode, substantial equivalent to repeat pulse mode of the predicate device), while the predicate device offers CW, single pulse, and repeat pulse modes. Both devices provide CW mode and pulsed modes for soft tissue surgical applications. The difference in pulse mode terminology does not affect the safety or performance of the devices. ### Note 2: The subject device uses TEC (Thermoelectric Cooling) combined with air cooling, while the predicate device uses air cooling only. TEC provides more efficient and stable thermal management for the laser diode, enhancing device reliability and longevity. This difference does not affect clinical performance or safety. ### Note 3: The subject device specifies input power of 500VA, while the predicate device specifies 4A-2A at 100-240VAC. Both are equivalent and compatible with standard mains supply (100-240VAC, 50/60Hz). The difference in specification format does not affect safety or performance. ### Note 4: The subject device has dimensions of \( 343 \times 230 \times 318 \) mm and weighs 10kg, while the predicate device measures \( 29 \times 25 \times 13 \) cm and weighs \( \leq 8 \) kg. The differences in size and weight are due to design choices (larger touchscreen, enhanced TEC cooling system, dual-wavelength integration) and do not affect clinical safety or performance for the intended use. ### Note 5: The subject device's 650nm wavelength and the reference device's 650nm wavelength are the same. ### Note 6: The subject device's 0.1-0.2W power range for 650nm falls within the predicate's 0.1-4W range. For 5 {16} LLLT applications, both devices utilize the same low-power output levels (0.1-0.2W) to achieve temporary relief of minor muscle and joint pain, stiffness, arthritis pain, muscle spasm, and temporary increase in local blood circulation. The predicate's higher maximum power (4W) is not relevant to the LLLT indication being compared. # Note 7: The subject device's pulse width, 10ms–1s (CW available), is within the range of the pulse width of the predicate device, 10ms–10s (CW available). # Note 8: The subject device repetition rate, 0.5 to 50 Hz, is within the range of the predicate's repetition rate (up to 100Hz). ## 9. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices. 6 --- **Source:** [https://fda.innolitics.com/device/K262349](https://fda.innolitics.com/device/K262349) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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