CO2 Laser System (MBT- CO2 Laser)

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 1, 2026 Beijing Mega Beauty Technology Co., Ltd. % Wang Ray General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Bldg. #15, Xiyuehui, #5, Yihe N. Rd. Fangshan District Beijing, 102401 China Re: K262269 Trade/Device Name: CO2 Laser System (MBT- CO2 Laser) 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 3, 2026 Received: July 6, 2026 Dear Wang Ray: 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 {1} K262269 - Wang Ray Page 2 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 {2} K262269 - Wang Ray Page 3 (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-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 L. HITHE -S Digitally signed by TANISHA L. HITHE -S Date: 2026.09.01 14:22:59 -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} # Indications for Use | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K262269 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | CO2 Laser System (MBT- CO2 Laser) | | | | | Please provide your Indications for Use below. | | | ? | | The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, pediatric, dental and otorhinolaryngology. | | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☐ Adults (22 years old and greater) | | ? | {4} 510(k) Summary # 510(K) Summary of K262269 This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92. 1. Date of Submission: 08/17/2026 2. Sponsor Identification **Beijing Mega Beauty Technology Co., Ltd.** Room 1-524, Building No.4, Xingyuan Road No.27, Daxing District, Beijing, 102629 Contact Person: Alex Yu Position: General Manager Tel: +86-13581869234 Email: alex@mbt-laser.com 3. Designated Submission Correspondent **Beijing Believe-Med Technology Service Co., Ltd.** Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China, 102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com 4. Identification of Proposed Device Trade Name: CO2 Laser System Common Name: CO2 Laser System Model(s): MBT- CO2 Laser Regulatory Information Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery Page 1 of 4 {5} 510(k) Summary ### 5. Identification of Predicate Device(s) 510(k) Number: K200042 Product Name: CO2 Laser System Manufacturer: Beijing Superlaser Technology Co., Ltd. ### 6. Device Description: The CO2 Laser System has three modes: single pulse mode, continuous mode and pulse mode. It utilizes CO2 laser to vaporize and heat tissue. During the treatment, the water in skin tissues absorbs laser energy and then vaporizes. Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through a LCD touch-screen. The CO2 Laser System is a software-controlled device. The physician enters treatment parameters on the touch screen and places the Light Guide Arm on the treatment site. A treatment is initiated by the physician to cause laser energy to be projected into the skin of a patient. The device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components. ### 7. Indication For Use Statement: The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. ### 8. Substantially Equivalent (SE) Comparison Table 1 General Comparison | ITEM | Proposed Device | Predicate Device (K200042) | Remark | | --- | --- | --- | --- | | Product Code | GEX | GEX | SAME | | Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME | | Class | 2 | 2 | SAME | | Where used | Hospital | Hospital | SAME | | Indication for Use | The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | SAME | Page 2 of 4 {6} 510(k) Summary Table 2 Performance Comparison | ITEM | Proposed Device | Predicate Device (K200042) | Remark | | --- | --- | --- | --- | | Maximum Power | 30W | 30W | SAME | | Work mode | Surgery (Single Pulse, Continuous, Pulse) | Surgery (Single Pulse, Continuous, Pulse) | SAME | | Wavelength | 10.6μm | 10.6μm | SAME | | Beam delivery | 7 joint light guide arm | 7 joint light guide arm | SAME | | Aiming Beam | Red indicator light (630-650nm, < 0.39mW) | Red indicator light (650nm, ≤ 5 mW) | Analysis 1 | | Spot size | 0.5 mm | 0.5 mm | SAME | | Output Power | Pulse: 1-30W | Pulse: 1-30W | SAME | | | Single: 1-30W | Pulse: 1-30W | | | | Continuous: 1-30W | Continuous: 1-30W | | | Pulse Duration | Single Pulse Mode: 1-1000 ms Pulse Mode: 1-1000 ms | Single Pulse Mode: 1-1000 ms Pulse Mode: 1-1000 ms | SAME | | Control System | Touch screen, footswitch | Touch screen, footswitch | SAME | | Laser operation | Footswitch | Footswitch | SAME | | Laser medium / energy source | CO2 | CO2 | SAME | | Cooling System | Air cooling | Closed inner circulating water cooling | Analysis 2 | | Clean Method | 70% isopropyl alcohol | 70% isopropyl alcohol | SAME | | Dimension | 55 cm ×36 cm ×159 cm | 37.5 cm × 29 cm × 113 cm | Analysis 2 | | Weight | 44kg | 40kg | Analysis 2 | | Power input | 110 V ±10%, 60Hz | 110V 60Hz or 230V 50Hz | SAME | Table 3 Safety Comparison | ITEM | Proposed Device | Predicate Device (K200042) | Remark | | --- | --- | --- | --- | | EMC, Electrical and Laser Safety | | | | | Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SAME | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME | | Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | SAME | ### Analysis 1: The proposed device is different in Aiming Beam from the predicate device. However, the indicator light of the proposed device does not affect the safety and effectiveness of the product. By complying with IEC 60601-1, IEC 60825-1 the mechanical performance of the proposed device is determined to be accepted. Therefore, this difference will not affect safety and effectiveness of the proposed device. Page 3 of 4 {7} 510(k) Summary # Analysis 2: The proposed device is different in Cooling System, Dimension and Weight from the predicate device. However, the indicator light of the proposed device does not affect the safety and effectiveness of the product. By complying with IEC 60601-1, IEC 60601-1-2 the mechanical performance of the proposed device is determined to be accepted. Therefore, this difference will not affect safety and effectiveness of the proposed device. # 9. 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: ➤ IEC 60601-1:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ➤ IEC 60601-1-2:2020 Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests ➤ 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 ➤ 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 # 10. Clinical Test Conclusion No clinical study is included in this submission. # 11. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device CO2 Laser System (K200042). Page 4 of 4