(245 days)
Not Found
No
The summary describes a standard laser system with control functions and scanning capabilities, but there is no mention of AI, ML, image processing, or any data-driven decision-making processes.
No
The device is described as "Medical Non-ablative Fractional Laser Systems" intended for dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. While these procedures can be part of a treatment plan, the device itself is described in terms of its function in performing those procedures, rather than its direct role in providing therapy. It is a tool used for a procedure, not a therapeutic device by its description. Additionally, one of the compliance standards listed is "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," which implies it could be therapeutic but doesn't explicitly state it is. The primary descriptions focus on "skin resurfacing and coagulation."
No
The "Intended Use / Indications for Use" section states the device is intended for "dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue," which are therapeutic treatments, not diagnostic functions. The device description also focuses on laser emission and scanning for treatment, not for identifying or analyzing medical conditions.
No
The device description explicitly states it includes hardware components: Main Console, Connector, and Scan Handpiece, which are integral to its function as a laser system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is clearly stated as "dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue." This describes a therapeutic or cosmetic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a laser system designed for direct application to the skin. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related terms: There are no mentions of analyzing samples (blood, urine, tissue, etc.), diagnostic testing, or any other activities typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This laser system does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
ONG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
No Clinical Test conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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
-
- Date of Preparation
04/26/2020
- Date of Preparation
-
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
-
- Submission Correspondent
Mr. Ray Wang
- Submission Correspondent
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
-
- Identification of Proposed Device
Trade Name: Medical Non-ablative Fractional Laser Systems Common Name: Medical Non-ablative Fractional Laser Systems Model(s): WFB-01
- Identification of Proposed Device
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.
-
- 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.
- Device Description
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
-
- Identification of Predicate Device
Predicate Device: 510(k) Number: K170060 Product Name: M22 And Resurfx Systems Manufacturer: Lumenis, Ltd.
- Identification of Predicate Device
-
- 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:
- Non-Clinical Test Conclusion
-
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.
-
- 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.