CO2 Laser System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 15, 2022 Smedtrum Medical Technology Co., Ltd. Crimson Wu Senior Regulatory Engineer 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City, Xinzhuang Dist. 248016 Taiwan Re: K221597 Trade/Device Name: CO2 Laser System 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 3. 2022 Received: August 3, 2022 Dear Crimson Wu: 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 mediation-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 Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221597 Device Name CO2 Laser System Indications for Use (Describe) The CO2 Laser System is used for body soft tissue ablation, vaporization and coagulation in dermatology, plastic surgery and general surgery. | 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. 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Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426 # Section 5 : 510(k) Summary CO2 Laser System (K221597) #### I. SUBMITTER Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016, Taiwan (R.O.C.) Contact Person Crimson Wu Position: Senior Regulatory Engineer Tel: +886-2-2298-9578, Ext. 301 Fax: +886-2-2298-9426 E-mail: crimsonwu@smedtrum.com Date of preparation: May 31th, 2022 #### II. DEVICE | Trade Name: | CO2 Laser System | |-----------------------|---------------------------------------| | Common or Usual Name: | Surgical Laser Device | | Classification Name: | GEX-Powered Laser Surgical Instrument | | | 21 C.F.R. § 878.4810, Device Class II | #### III. PREDICATE DEVICE | Trade Name: | CO2 Laser Therapy System | | | |-------------------------|---------------------------------------|----------------|--| | Common or Usual Name: | Surgical Laser Device | | | | Classification Name: | GEX-Powered Laser Surgical Instrument | | | | | 21 C.F.R. § 878.4810, Device Class II | | | | Premarket Notification: | K201109 | Sep 15th, 2020 | | #### IV. DEVICE DESCRIPTION CO2 Laser System is a carbon dioxide surgical laser device intended for prescription use and is comprised mainly of three components: console, articulated arm and footswitch.CO2 Laser System contains a radio-frequency excited CO2 laser tube which generates laser sources at nominal wavelength of 10,600 nm. As CO2 laser radiation is invisible; therefore, a low-power, visible aiming laser source (650 mm) is required to position the treatment laser beam. The output of laser beam is delivered through articulated arm to a fractional handpiece or normal handpiece. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The physician activates laser emission by means of a footswitch. The fractional handpiece is suited mainly for general surgical application. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains a logo for a medical technology company. On the left side of the logo is a blue and gray geometric shape. To the right of the shape is the company name, "Smedtrum MEDICAL TECHNOLOGY CO.,LTD." When the laser contacts human tissue, the laser energy is absorbed by water in the target tissue, resulting in a very rapid, highly localized temperature increase to the tissue. The instantaneous temperature-increase heats up the water and causes evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the treatment area, causing tissue coagulation which induces hemostasis as well as thermal stimulation of deep skin layers, that inducing fibroblast stimulation and neocollagenesis. The CO2 Laser System is capable of producing continuous-wave, pulsed laser or fractional laser radiation. The physician can optimize the parameter for different applications by adjusting the energy of laser pulse and output pattern. #### INDICATIONS FOR USE V. The CO2 Laser System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery. #### COMPARISON OF TECHNOLOGICAL CHARATERISTICS WITH THE VI. | Feature | Proposed device | Predicate device<br>(K201109) | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | CO2 Laser System | CO2 Laser Therapy System | | Product Code | GEX | GEX | | Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | | Device Class | Class II | Class II | | Indication for<br>Use | The CO2 Laser System is used<br>for body soft tissue ablation,<br>vaporization, excision and<br>coagulation in dermatology,<br>plastic surgery and general<br>surgery. | The CO2 Laser Therapy<br>System is used for body soft<br>tissue vaporization and<br>coagulation in dermatology and<br>plastic surgery, general surgery,<br>gynecology. | | Laser Type | RF Sealed-off CO2 | RF Sealed-off CO2 | | Laser<br>Classification | Class 4 | Class 4 | | CO2 Laser<br>Wavelength | 10600 nm | 10600 nm | | Aiming Beam<br>Wavelength | <2 mw /650 nm<br>/Semiconductor Laser LD | < 2 mw /650 nm<br>/Semiconductor Laser LD | | Max. Aiming<br>Beam Power<br>Watts | 2 mW | 2 mW | | Laser Delivery<br>System | Articulated arm with<br>counterweight | Articulated arm with<br>counterweight | | Beam Delivery<br>Handpiece | 2 Normal Handpieces or 1<br>Fractional Handpiece | 2 Normal Handpieces or 1<br>Fractional Handpiece | | Laser firing<br>Controls | LCD color Touchscreen<br>Footswitch | LCD color Touchscreen<br>Footswitch | ## PREDICATE DEVICE {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains a logo for Smedtrum Medical Technology Co., LTD. The logo features a stylized teal and gray geometric shape on the left. To the right of the shape is the company name in both Chinese and English. The word "Smedtrum" is in a larger, light gray font. Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426 | Feature | Proposed device | | Predicate device<br>(K201109) | | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------| | Max. Output<br>Power Watts | 35 W | | HS-411: 35 W | | | | | | HS-411A: 55 W | | | Scan Area Size | 2x2 mm~20x20 mm | | 2x2 mm~20x20 mm | | | Pulse | CW | NA | CW | NA | | | Single | 1~375 ms | Single | 10~500ms | | Duration | Pulse | Pulse width:<br>5~375 ms<br>Delay time:<br>1~500 ms | Pulse | On time: 5~500 ms<br>Off time:<br>1-500 ms | | | S-Pulse | Pulse width:<br>1~4 ms<br>Delay time:<br>1~100 ms | S. Pulse | On time: 1~4 ms<br>Off time:<br>1-100 ms | | | U-pulse | Pulse width:<br>0.1-0.9 ms<br>Delay time:<br>1-100 ms | U pulse | On time:<br>0.1-0.9 ms<br>Off time:<br>1-100 ms | | Fractional<br>Pulse Energy | 1-300 mJ/dot | | 1-300 mJ/dot | | | Spot Size | 120 μm | ( fractional ) | 150 µm | ( fractional ) | | Spot Density<br>(DPA)/ cm² | 25, 36, 49, 64, 81, 100, 121,<br>144, 169, 196, 225, 256, 289,<br>324, 361, 400, 441, 484, 529,<br>784, 1024, 1521, 2025, 2500,<br>3025 dots. | | 25, 36, 49, 64, 81, 100, 121,<br>144, 169, 196, 225, 256, 289,<br>324, 361, 400, 441, 484, 529,<br>784, 1024, 1521, 2025, 2500,<br>3025 dots. | | | Operational<br>Mode | Fractional mode, and normal<br>mode (CW, Single, Pulse, S.<br>pulse, U. pulse) | | Fractional mode, and normal<br>mode (CW, Single, Pulse, S.<br>pulse, U. pulse) | | | Cooling<br>System | Forced-air cooling | | Forced-air cooling | | | Power Input | 100-240VAC, 50/60 Hz | | 100-240VAC, 50/60 Hz | | | Dimension | 188 cm x 61 cm x 53.4 cm<br>(H x W x D) | | 113 cm x 45 cm x 50 cm<br>(H x W x D) | | | Weight | 50 Kg | | 55 Kg | | | Software | Yes. Verification and validation<br>testing of the software are<br>performed | | Yes | | ## VII. PERFORMANCE DATA The CO2 Laser System has been determined through engineering testing to verify laser energy output and electrical safety. Electrical safety and electromagnetic compatibility The test results demonstrated that the proposed device complies with the following standards: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Smedtrum Medical Technology Co., LTD. The logo features a geometric design on the left, consisting of overlapping triangles in shades of blue and gray. To the right of the geometric design is the company name, with "Smedtrum" in a larger, bolder font and "MEDICAL TECHNOLOGY CO.,LTD." in a smaller font below it. Above the company name, in a smaller font, is the company name in Chinese. IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements IEC 60601-2-22:2007(third edition)+A1:2012 for use in conjunction with IEC 60601-1:2005 (third edition)+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Software Verification and Validation Testing Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern since a failure of the software could result in minor injury to a patient or to a user of the device. ### Sterilization and Shelf-Life The proposed device is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with isopropyl alcohol or ethanol of 70% strength or higher. The proposed device is reusable and does not have a restricted shelf-life. ### VIII. CONCLUSION The CO2 Laser System has the same intended use, similar indications for use, the same technological characteristics, the same energy used, and the same operating principles as its predicates. The non-clinical data and performance testing reports in this submission demonstrate that CO2 Laser System meets the expected performance requirements. Any difference between the subject and predicate device do not raise new issues of safety or effectiveness. Based on above analysis, the CO2 Laser System is substantial equivalent to the cited predicate device.