Diode laser therapy device

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 6, 2023 Triangel Rsd Limited % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China Re: K212734 Trade/Device Name: Diode laser therapy device 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: April 28, 2023 Received: May 1, 2023 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 (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 located 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}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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. Jianting Wang -S Jianting Wang Acting 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212734 Device Name Diode laser therapy device #### Indications for Use (Describe) The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact mode during surgical procedures. The device's 980mm laser is generally indicated for use in incision, 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 intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. | | Type of Use (Select one or both, as applicable) | | |--|-------------------------------------------------|--| | | | | X 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." {3}------------------------------------------------ # 510(k) Summary #### 510(k) number: K212734 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: TRIANGEL RSD LIMITED Address: Center Building 4, C Unit 324, #3088, Lekai North Street, Power Valley Technology, Baoding City, Heibei, China Phone Number: 86-18931273229 Contact: Zhao Fengdan Email: triangelrsd@triangelaser.com Date of Preparation: Jun.02, 2023 ## 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 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn ### 2.0 Device information | Trade name: | Diode laser therapy device | |------------------|----------------------------------------------------------------------------------------| | Common name: | Powered Laser Surgical Instrument | | Regulation name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology | | Model(s): | ST-AR. | ### 3.0 Classification Production code: GEX Regulation number: 21 CFR 878.4810 Classification: Class II General & Plastic Surgery Panel: # 4.0 Predicate device information {4}------------------------------------------------ 510(k) Number: K081015 Product Name: Ceralas Diode 980nm Laser System Manufacturer: Biolitec, Inc. 510(k) Number: K073063 Product Name: 15W Ceralas Diode 1470nm Laser System Manufacturer: Biolitec, Inc. ### 5.0 Indication for Use Statement 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, 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 delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. ### 6.0 Device description The diode laser generates a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coaqulation of the target tissue. The diode laser generates 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 Diode laser therapy device has following characteristics: - Dual wavelengths A - A Temperature monitoring system # 7.0 Non-Clinical Test Conclusion | Item | Technical specification | |--------------------|---------------------------------------------| | Wavelength | 980nm±5nm, 1470nm±5nm | | Max Power | 16W/980nm±20%, 4.5W/1470nm±20%, 0.5mw/650nm | | Security Level | Class IV type B | | Laser Output Mode | Continuous, Pulse, Single. | | Pulse Width | 0.05ms-1s (stepping 0.05, 0.1ms) | | Cooling | Air Cooling | | Size | 38×46.5×22.5cm | | Net Weight | 8KG | | Fuse | ⌀5×25, 2A | | Laser Output Power | 16W/980nm±10%, 4.5W/1470nm±10% | #### Table 1 - Product Technical Specification {5}------------------------------------------------ | | 0.05mw/650nm | |----------------|-----------------------------------------------| | Fiber Diameter | Φ400 | | Aiming beam | 650 nm, red 0.5 mW, user controlled intensity | | Treatment mode | Continuous, Pulse, Single. | ### Table 2 - Biocompatibility testing for components contacting patients | Item | Proposed Device | Result | |--------------------------|---------------------------------------------------------------------------------|--------| | Cytotoxicity | Under the conditions of the study, the device is noncytotoxic. | Pass | | Irritation | Under the conditions of the study, the device is nonirritating. | Pass | | Sensitization | Under the conditions of the study, the device is nonsensitizing | Pass | | Aucte systemic toxicity, | Under the conditions of the study, the device does show aucte systemic toxicity | Pass | | Pyrogen test | Under the conditions of the study, the device does show pyrogen | Pass | | In vitro hemolytic test | Under the conditions of the study, the device does show In vitro hemolytic risk | Pass | # 8.0 _Clinical Test Conclusion No clinical study implemented for the Diode laser therapy device. # 9.0 Technological Characteristic Comparison Table {6}------------------------------------------------ | Item | Proposed device | Predicated device | Remark | | |----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---| | Product Code | GEX | GEX | Identical | | | Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical | | | Class | II | II | Identical | | | Product name | Diode laser therapy device | Ceralas Diode 980nm Laser System | 15W Ceralas Diode 1470nm<br>Laser System | | | 510(k) No. | K212734 | K081015 | K073063 | - | | Models | ST-AR | D15 | D1470 | - | | Intended use | The Diode laser therapy device is<br>intended for delivery of laser light to soft<br>tissue in the contact and non contact<br>mode during surgical procedures. The<br>device's 980nm laser is generally<br>indicated for use in incision, excision,<br>vaporization, ablation, hemostasis or<br>coagulation of soft tissue in ear, nose and<br>throat and oral surgery (otolaryngology),<br>dental procedures, gastroenterology,<br>general surgery, dermatology, plastic<br>surgery, podiatry, urology, gynecology.<br>The device is further indicated for laser<br>assisted lipolysis. | The Ceralas D 980 is intended for<br>delivery of laser light to soft tissue in the<br>contact or noncontact mode during<br>surgical procedures, including via<br>endoscopes, introducers, or catheters.<br>The Ceralas D 980 is generally indicated<br>for incision, excision, vaporization,<br>ablation, hemostasis, or coagulation of<br>soft tissue in ear, nose and throat and<br>oral surgery (otolaryngology), dental<br>procedures, arthroscopy,<br>gastroenterology, general surgery,<br>dermatology, plastic surgery,<br>podiatry, urology, gynecology,<br>neurosurgery (peripheral nervous<br>system), pulmonary surgery, and<br>cardiothoracic surgery, and | * Gap 1 | | {7}------------------------------------------------ | | | ophthalmology. This Ceralas D 980 is<br>specifically indicated for laser assisted<br>lipolysis. | | | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | The device's 1470nm laser is intended<br>for delivery of laser light to soft tissue in<br>non-contact mode during general surgery<br>procedures, indicated for the treatment of<br>reflux of the saphenous veins associated<br>with varicose veins and varicosities. | | The Ceralas D1470 is a diode<br>laser that is intended for delivery<br>of laser light to soft tissue in<br>non-contact mode during<br>general surgery procedures.<br>The device is indicated for the<br>treatment of reflux of the<br>saphenous veins associated<br>with varicose veins and<br>varicosities. | Same | | Patient<br>Population | Adult | Adult | Adult | Same | * Gap analysis: Gap 1: The proposed device does not use with the endoscope, the indication of Arthroscopy, Cardiothoracic Surgery, Neurosurgery, treatment of reflux of the saphenous veins and varicosities, which the predicate device applies does not apply to the proposed device, less indication will not bring additional risks to the proposed device. Gap 2: The proposed device defines specific contraindication which does not bring additional clinical risk for the product use. #### Table 4- Performance Comparison | Item | Proposed Device | Predicate Device | Remark | |------|----------------------------|------------------------------------------------------------------------------|--------| | | Diode laser therapy device | Ceralas Diode 980nm Laser System<br>15W Ceralas Diode 1470nm Laser<br>System | | | | K212734 | K081015<br>K073063 | | {8}------------------------------------------------ | Wavelength | 980nm±5nm,1470nm±10nm | 980 nm | 1470 nm | Same | |----------------------|---------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|---------| | Output Power max. | 16W/980nm±20%,<br>4.5W/1470nm±20% | 15 Watt | 15 Watt | * Gap 2 | | Aiming beam | 650 nm, red 0.5 mW, user<br>controlled intensity | 635 nm, red 4 mW, user controlled<br>intensity | 635 nm, red 4 mW, user controlled<br>intensity | * Gap 3 | | Treatment mode | Continuous or Pulsed | Continuous or Pulsed | Continuous or Pulsed | Same | | Power supply | AC110V±11V, 60HZ | 110/220 V | 110/220 V | * Gap 4 | | Interval | 980nm 1% ~ 100%,<br>1470nm 2% ~100%,<br>continuously adjustable<br>energy | 980nm 1% ~ 100%, continuously<br>adjustable energy | 1470nm 2% ~100%, continuously<br>adjustable energy | Same | | Cooling system | Air cooled | Air cooled | Air cooled | Same | | Fiber (applied part) | Sterile, for single use | Single use or repeated use | Single use or repeated use | * Gap 5 | * Gap analysis: 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. For 1470m max power of the proposed device is different to the predicate device, we collect clinical survey data, and clinical literature which can support the efficacy of the 4.5W is effective to realize its intended performance, the lower 4.5W can risks compared to predicate device. Gap 3, the aiming beam of the two device 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. Gap 5, the fiber (applied part) of the proposed device is for single use, sterile, which will not create addtional risks compared to the equivalence device. #### Table 5- Safety Comparison | Item | Proposed Device | Predicate Device | Remark | |------|-----------------|------------------|--------| |------|-----------------|------------------|--------| {9}------------------------------------------------ | | Diode laser therapy device | Ceralas Diode 980nm Laser<br>System | 15W Ceralas Diode 1470nm<br>Laser System | | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------| | | K212734 | K081015 | K073063 | | | Materials<br>contacting user | Fiber | Fiber | Fiber | Same | | Biocompatibility of<br>materials<br>contacting user | Cytotoxicity, Comply with ISO<br>10993-5;<br>Irritation, Sensitization, comply<br>with ISO 10993-10;<br>Aucte systemic toxicity,<br>Pyrogen test comply with ISO<br>10993-11;<br>In vitro hemolytic test comply<br>with ISO 10993-4. | Cytotoxicity, Comply with ISO<br>10993-5;<br>Irritation, Sensitization, comply<br>with ISO 10993-10 | Cytotoxicity, Comply with ISO<br>10993-5;<br>Irritation, Sensitization, comply<br>with ISO 10993-10 | Gap 6 | | Electric safety | Comply with IEC<br>60601-1:2005+A1:2012, IEC<br>60825-1:2014,<br>IEC 60601-2-22:2007+A1:2012 | Comply with IEC 60601-1, IEC<br>60825-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC<br>60825-1, IEC 60601-2-22 | Same | | EMC | Comply with IEC<br>60601-1-2:2014 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | * Gap analysis: Gap 6: the proposed device implement more biccompatibility study for the device, which does not create additional risks for product use {10}------------------------------------------------ #### 10.0 Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Diode laser therapy device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K081015, K073063.