(90 days)
Not Found
No
The summary describes a laser therapy system with different operational modes and modules. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of AI/ML. The performance studies focus on compliance with electrical and biological safety standards, not AI/ML performance metrics.
Yes
The device is described as a "Fractional CO2 Laser Therapy System" and its intended use is for "ablation, vaporization and coagulation of body soft tissues," which are therapeutic actions.
No
Explanation: The device is a Fractional CO2 Laser Therapy System indicated for ablative skin resurfacing and for incision, ablation, vaporization, and coagulation of body soft tissues. These are therapeutic uses, not diagnostic ones.
No
The device description explicitly lists multiple hardware modules (Control Display Panel Module, Articulated arm Module, Fan Cooling Module, Laser Module, and Foot switch module), indicating it is a physical device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a Fractional CO2 Laser Therapy System used for procedures like incision, ablation, vaporization, and coagulation of body soft tissues. These are direct treatments performed on the patient's body, not tests on samples outside the body.
- Intended Use: The intended use describes surgical and aesthetic procedures, not diagnostic testing.
- Device Description: The components listed (laser module, articulated arm, etc.) are consistent with a surgical laser system, not an IVD.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
Product codes
GEX, ONG
Device Description
The Fractional CO2 Laser Therapy System has two operational modes: fractional mode and non-fractional mode.
The Fractional CO2 Laser Therapy System has 6 modules: Control Display Panel Module, Main Control program Module, Articulated arm Module, Fan Cooling Module, Laser Module and Foot switch module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body soft tissues including intraoral tissues
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 testing was conducted to verify that the proposed device met design specifications. The test results demonstrated that the proposed device conforms to the following performance standards:
- 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
- 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 disturbances -Requirements and tests
- 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
- IEC 60825-1: 2014 Safety of laser products - Part 1: Equipment classification, and requirements
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 23, 2024
Weifang Mingliang Electronics CO., LTD. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 China
Re: K242183
Trade/Device Name: Fractional CO2 Laser Therapy System (EXFU CO2) 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, ONG Dated: July 25, 2024 Received: July 25, 2024
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 (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/cdrb/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.
1
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.
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to. 21 CFR 820.30. Design controls: 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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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,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE - ○ Date: 2024.10.23
14:03:24 -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
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Indications for Use
510(k) Number (if known) K242183
Device Name Fractional CO2 Laser Therapy System (EXFU CO2)
Indications for Use (Describe)
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
| 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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The assigned 510(k) Number: ____________ K242183
510(k) Summary
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.
- Date of Preparation: 10/18/2024 1.
-
- Sponsor Identification
Weifang Mingliang Electronics CO., LTD.
1-301, Building 15, Phase 1, Yuandu Huizhi Industrial Complex, No.3999, Taixiang Street, Weifang Economic Development Zone, 261000, Shandong, P.R. China Contact Person: Alisa Lv Position: Deputy Director of Support Center Tel: +86-15966114613 Email: 15966114613@139.com
-
- 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
-
- Identification of Proposed Device
Trade Name: Fractional CO2 Laser Therapy System (EXFU CO2) Common Name: Powered Laser Surgical Instrument
- Identification of Proposed Device
Regulatory Information Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX; ONG Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in
5
dermatology.
Regulation Medical Specialty: General & Plastic Surgery Review Panel: General & Plastic Surgery
Indication For Use Statement:
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
- న్. Device Description
The Fractional CO2 Laser Therapy System has two operational modes: fractional mode and non-fractional mode.
The Fractional CO2 Laser Therapy System has 6 modules: Control Display Panel Module, Main Control program Module, Articulated arm Module, Fan Cooling Module, Laser Module and Foot switch module.
-
Identification of Predicate Device(s) 6.
Predicate Device 510(k) Number: K172096 Product Name: Ilooda Fraxis CO2 Laser Manufacturer: Ilooda Co. LTD -
- Non-Clinical Test Conclusion
Non-clinical testing was conducted to verify that the proposed device met design specifications. The test results demonstrated that the proposed device conforms to the following performance standards:
- Non-Clinical Test Conclusion
-
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
-
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 A
6
basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
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
-
IEC 60825-1: 2014 Safety of laser products - Part 1: Equipment classification, and requirements
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
Table 1 Comparison
| Item | Proposed Device (K242183) | Predicate Device (K172096) | Remark | ||
|---|---|---|---|---|---|
| Indications for Use | Fractional mode is indicated only for | ||||
| ablative skin resurfacing. | |||||
| Non-fractional mode is indicated for | |||||
| incision, excision, ablation, | |||||
| vaporization and coagulation of body | |||||
| soft tissues including intraoral tissues, | |||||
| in medical specialties including | |||||
| aesthetic (dermatology and plastic | |||||
| surgery), otorhinolaryngology (ENT), | |||||
| gynecology, neurosurgery, dental and | |||||
| oral surgery and genitourinary surgery. | - CO2 LASER Part: | ||||
| Fractional mode is indicated only for | |||||
| ablative skin resurfacing. | |||||
| Non-fractional mode is indicated for | |||||
| incision, excision, ablation, | |||||
| vaporization and coagulation of body | |||||
| soft tissues including intraoral tissues, | |||||
| in medical specialties including | |||||
| aesthetic (dermatology and plastic | |||||
| surgery), otorhinolaryngology (ENT), | |||||
| gynecology, neurosurgery, dental and | |||||
| oral surgery and genitourinary surgery. | SAME | ||||
| Product Code | GEX, ONG | GEX, ONG | SAME | ||
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME | ||
| Laser Type | CO2 | CO2 | SAME | ||
| Laser wavelength | 10.6μm | 10.6μm | SAME | ||
| Maximum Output power | 30W | 30W | SAME | ||
| Pulse Duration | 20μs – 5000μs | 20-5,000μs | SAME | ||
| Fractional Pulse energy | Max 150mJ | Max 150mJ | SAME | ||
| Repetition rate | 1,000Hz | 1,000Hz | SAME | ||
| Scan area | 20x20mm | 20x20mm | SAME | ||
| Spot size | 100-200μm | 100-200μm | SAME | ||
| Non-fractional: Max 1.3mm | Non-fractional: Max 1.3mm | ||||
| Number of microbeams | |||||
| per surface area | Max 289 spot/cm² | Max 289 spot/cm² | SAME |
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510(k) Summary
| Energy per microbeam
| (fractional) | 150mJ | 150mJ | SAME |
|---|---|---|---|
| Total power per | |||
| surfaced area | |||
| (fractional) | Max 30W | Max 30W | SAME |
| Treatment Time | 10-15 min | 10-15 min | SAME |
| Pulse rate | |||
| (nonfractional) | 1Hz - 1,000Hz | 1Hz - 1,000Hz | SAME |
| Pulse width | |||
| (nonfractional) | 20μs – 5000μs | 20μs – 5000μs | SAME |
| Operational mode | Fractional mode, normal mode | ||
| (CW, Pulse, Single Pulse) | Fractional mode, normal mode | ||
| (CW, Pulse, Single Pulse) | SAME | ||
| Aiming beam | Diode laser(Red), Max 3mW | Diode laser(Red), Max 4mW | Different 1 |
| Cooling | Air cooling | Air cooling | SAME |
| User Interface | LCD touch screen | LCD touch screen | SAME |
| Optical guide | Articulated arm | Articulated arm | SAME |
| Electrical Requirements | 110-240V, 50/60Hz | 100-240VAC, 50-60 Hz | Different 2 |
Analysis 1:
The output intensity of the output device's red laser aiming beam is less that that of the predicate device. The intensity however, is adequate in order to provide feedback regarding the beam's location to the device user.
Analysis 2:
The proposed device's input voltage range of 110 – 240 V, 50/60 Hz is different from the input voltage range of the predicate device. This 510(k)'s documentation however, included a test report per the IEC 60601-1 performance standard, and from the testing results the device is considered to conform to the requirements.
10. Substantially Equivalent (SE) 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 (K172096).