← Product Code [ONG](/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG) · K192350 # Medical Non-Ablative Fractional Laser Systems (K192350) _Wingderm Electro-Optics , Ltd. · ONG · Apr 30, 2020 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K192350 ## Device Facts - **Applicant:** Wingderm Electro-Optics , Ltd. - **Product Code:** [ONG](/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG.md) - **Decision Date:** Apr 30, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. ## Device Story Medical Non-ablative Fractional Laser System (WFB-01) is a laser surgical instrument for dermatology. System comprises main console, connector, and scan handpiece with three interchangeable scan heads (AccuTip, EffiTip, GrowTip). Device utilizes 1550 nm Er:Glass laser to deliver fractional energy to skin. Operator controls system via console interface; handpiece performs graphic scanning of treatment area. Output consists of laser micro-beams for skin resurfacing and soft tissue coagulation. Used in clinical settings by trained professionals. Device provides controlled thermal injury to skin, promoting resurfacing; clinical benefit derived from non-ablative fractional treatment of dermatological conditions. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing and performance comparisons. ## Technological Characteristics Er:Glass laser; 1550 nm wavelength; 15 W power; 110 um beam diameter; 10 ms pulse duration. Includes main console, connector, and scan handpiece. Complies with AAMI/ANSI/ES 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2. Biocompatibility per ISO 10993-5 and ISO 10993-10. ## 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 - M22 And Resurfx Systems ([K170060](/device/K170060.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/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Wingderm Electro-Optics Ltd. % Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., Fangshan District Beijing, 102401 CN Re: K192350 Trade/Device Name: Medical Non-Ablative Fractional Laser Systems 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: ONG Dated: August 21, 2019 Received: August 29, 2019 Dear Ray 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. 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 {1}------------------------------------------------ 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, Colin Kejing Chen 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K192350 Device Name Medical Non-ablative Fractional Laser Systems (Model: WFB-01) Indications for Use (Describe) The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. | 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](mailto: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}------------------------------------------------ # Tab #3 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K192350 - 1. Date of Preparation 04/26/2020 - Sponsor 2. # Wingderm Electro-Optics Ltd. Room 312, Building D-3, Dongsheng Science Park, No.66 Xixiaokou Road, Haidian District, 100192 Beijing, China Contact Person: Juan Zhou Position: Quality Manager Tel: +86- 18513353536 Email: zhoujuan@wingderm.com - 3. Submission Correspondent Mr. Ray Wang # Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com {4}------------------------------------------------ - 4. Identification of Proposed Device Trade Name: Medical Non-ablative Fractional Laser Systems Common Name: Medical Non-ablative Fractional Laser Systems Model(s): WFB-01 ### Regulatory Information: Classification Name: Powered laser surgical instrument with microbeam\fractional output Classification: 2; Product Code: ONG; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery; ### Intended Use Statement: The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. - 5. Device Description The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) includes three main parts, Main Console, Connector and Scan Handpiece. The main console is used for system control, such as control of user interface, power on/off and other functions, and also used as holder for other components. The Connector is used to connect with accessories or power supplier, such as foot switch, pipeline holder, cold air device etc. The Scan Handpiece is used to provide laser emission and graphic scanning functions. It provides three scan heads (AccuTip, EffiTip, GrowTip) for treatment areas. {5}------------------------------------------------ - 6. Identification of Predicate Device Predicate Device: 510(k) Number: K170060 Product Name: M22 And Resurfx Systems Manufacturer: Lumenis, Ltd. - 7. 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: - > AAMI/ANSI/ES 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance; - > IEC 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment. - > IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements. - > 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 - > ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. - > ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. - > Performance Testing for Energy Output Accuracy. - 8. Clinical Test Conclusion No Clinical Test conducted. {6}------------------------------------------------ #### Substantially Equivalent (SE) Comparison 9. | ITEM | Proposed Device | Predicate Device
K170060 | Remark | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Product Code | ONG | GEX, ONF, ONG | SAME | | Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME | | Class | 2 | 2 | SAME | | Intended Use | The Medical Non-ablative Fractional
Laser Systems (Model: WFB-01) is
intended for use in dermatological
procedures requiring fractional skin
resurfacing and coagulation of soft tissue. | ResurFX module and handpiece, with
wavelength of 1565 nm, is indicated for Use
in dermatological procedures requiring
fractional skin resurfacing and coagulation
of soft tissue | SAME | | Prescription/
OTC | Prescription Use | Prescription Use | SAME | # Table 1 General Comparison # Table 2 Performance Comparison | ITEM | Proposed Device | Predicate Device
K170060 | Remark | |------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------| | Wavelengths | 1550 nm | 1565 nm | SAME | | Fluence | Up to 70 mJ per Micro-beam | Up to 70 mJ per Micro-beam | SAME | | Laser Power | 15 W | 15 W | SAME | | Dot Density
(Dot/cm²) | 500 | Up to 500 | SAME | | Laser Beam
Diameter | 110 um | 110 um | SAME | | Inter-beam
spacing | 0.4 mm - 1.0 mm | 0.4 mm - 1.0 mm | SAME | | Beam diameter
variability | Fixed | Fixed | SAME | | Pulse Duration | 10 ms | 10 ms | SAME | | Type of laser | Er:Glass | Er:Glass | SAME | | Tip treatment
Area | AccuTip: 10mmX10mm,
EffiTip: 20mmX20mm
GrowTip: 10mmX20mm | 18mm SapphireCool Tip
18mm Precision Tip | Analysis | | Scanning shapes | Rectangle, Hexagon, Ellipse, Triangle,
Circle | Line, square, rectangle, circle, donut,
hexagon, vertical line, and vertical rectangle | Analysis | # Difference Analysis: The design and technological characteristics of the subject device is basically similar to the predicate device chosen. There are minor differences between the devices including Treatment Area and Scanning shapes. These two specifications are only for different area but not affects the treatment power (fluence). So, there is no deleterious effect on safety and effectiveness due to the differences, and these minor {7}------------------------------------------------ differences do not influence the intended use function and use of the device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not raise any questions as to the safety and effectiveness. Therefore, the subject device is substantially equivalent to the Predicate device. | ITEM | Proposed Device | Predicate Device
K170060 | Remark | |-----------------------|-----------------------------------------------|-----------------------------------------------|--------| | Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SAME | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME | | Performance Test | Comply with IEC 60601-2-22 and IEC
60825-1 | Comply with IEC 60601-2-22 and IEC
60825-1 | SAME | | Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SAME | | Label and
Labeling | Conforms to FDA Regulatory
Requirements | Conforms to FDA Regulatory
Requirements | SAME | # Table 3 Safety Comparison ## 10. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K192350](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONG/K192350) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com