(58 days)
No reference devices were used in this submission.
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no description of training or test sets, which are typical for AI/ML devices. The description focuses on the laser technology and user interface.
Yes
The device's intended use is for incision, ablation, vaporization, hemostasis, and/or coagulation of soft tissue, which are actions performed to treat a medical condition.
No
The device is described as being used for incision, ablation, vaporization, hemostasis, and/or coagulation of soft tissue, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly lists hardware components such as a main unit, foot switch, power cord, and protective goggles, and describes a laser beam source and aiming beam diode. While software is mentioned and verified, it is part of a larger hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood.
- Device Description and Intended Use: The description clearly states the device is a "Medical Diode Laser" intended for "incision, ablation, vaporization, hemostasis and/or coagulation of soft tissue." This is a direct surgical or therapeutic intervention performed on the body, not an examination of specimens from the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological specimens.
Therefore, based on the provided information, this device is a surgical laser, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Medical Diode Laser is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.
Product codes
GEX
Device Description
The Medical Diode Laser use a wavelength 1940nm Galium Aluminum Arsenide (GaAlAs) diode laser as the beam source. The laser utilizes a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam The Medical Diode Laser (model: M2) is a compact diode laser with a LCD touchscreen for user control. The device is composed of main unit, foot switch, power cord and protective goggles. The fiber delivery system is not include in this device. The device accepts a fiber with single core of 400um and 600um in diameter and with SMA905 connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
RX only
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
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Medical Diode Laser and optical fibers. The Medical Diode Laser complies with the IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-2-22:2019 and IEC 60825-1:2014 standards for safety and the IEC 60601-1-2:2014+A1:2020 standard for EMC.
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 and the documentation was provided accordingly.
Summary
Based on the clinical performance, technological characteristics and performance data as documented in the submission, the Medical Diode Laser was found to have a safety and effectiveness profile that is same as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 31, 2023
Wuhan Pioon Technology Co.,Ltd. Feng Zhang Official Primary Correspondent and Management Representative 7th Floor, A21 of Sino Pharm Building, Biolake Innovation Park, No.666 Gaoxin Avenue Wuhan, Hubei 430075 China
Re: K230274
Trade/Device Name: Medical Diode Laser (M2) 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: January 30, 2023 Received: February 1, 2023
Dear Feng Zhang:
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 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,
Jianting Wang -S
Jianting Wang 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
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Indications for Use
Submission Number (if known)
K230274
Device Name
Medical Diode Laser (M2)
Indications for Use (Describe)
Medical Diode Laser is intended to incision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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."
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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.
The assigned 510(k) Number: K230274
- I. Submitter
| Device Submitter: Wuhan Pioon Technology Co.,Ltd. |
|---|
| 7th Floor, A21 of Sino Pharm Building, Biolake Innovation |
| Park, No.666 Gaoxin Avenue, East Lake High-tech |
| Development Zone,430075,Wuhan, Hubei, PEOPLE'S |
| REPUBLIC OF CHINA |
| Tel: +86 27 81783687 |
| Contact Person: | Zhang Feng, Official Primary Correspondent and
Management Representative |
|-----------------|-----------------------------------------------------------------------------|
| | Phone: +86 18062448535 |
| | E-mail: zhangfeng@pioon.com |
Date Prepared: December 8, 2022
| Type of 510(k): | Traditional |
|---|---|
| Trade name: | N/A, |
| Device name: | Medical Diode Laser, Model: M2 |
| Common Name: | Powered Laser Surgical Instrument |
| Regulation: | 878.4810 - Laser surgical instrument for use in general |
| and plastic surgery and in dermatology | |
| Medical Specialty: | General & Plastic Surgery |
| Regulatory Class: | II |
| Product Code: | GEX |
III. Predicate Device
Fotona SkyPulse Laser Platform (K193656), 1940nm Diode Laser. This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. Device Description
4
The Medical Diode Laser use a wavelength 1940nm Galium Aluminum Arsenide (GaAlAs) diode laser as the beam source. The laser utilizes a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam The Medical Diode Laser (model: M2) is a compact diode laser with a LCD touchscreen for user control. The device is composed of main unit, foot switch, power cord and protective goggles. The fiber delivery system is not include in this device. The device accepts a fiber with single core of 400um and 600um in diameter and with SMA905 connectors.
V. Indications for Use
Medical Diode Laser is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.
Comparison of Technological Characteristics with the Predicate Device VI.
The predicated device is Fotona SkyPulse Laser Platform (K193656), a 1940nm Diode Laser with same intended use as the subject device.
| Item | Subject device
(this submission) | Predicated device
(K193656) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GEX | GEX |
| Regulation NO. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | II | II |
| Indications for
Use | Medical Diode Laser is
intended to incision, excision,
ablation, vaporization,
hemostasis and/or coagulation
of soft tissue. | Medical Diode Laser is intended
to incision, excision, ablation,
vaporization, hemostasis and/or
coagulation of soft tissue. |
| Use of device | RX only | RX only |
| Energy source | Solid state diode | Solid state diode |
| Configuration | Main Unit
Foot Control | Main Unit
Foot Control |
| Laser
Wavelength | 1940nm | 1940nm |
| Laser
Classification | Class IV | Class IV |
| Power range | Up to 7.5W | Up to 7.5W |
| Pulse width | CW or 10 ms – 10 s | CW or 10 ms – 10 s |
| Repetition rate | CW or up to 100 Hz | CW or up to 100 Hz |
| Delivery system | Fiber delivery | Fiber delivery |
| User interface | Touch screen control | Touch screen control |
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Wuhan Pioon Technology Co., Ltd PN/FDA-M2-25
| Safety feature | Complied with: | Complied with: |
|---|---|---|
| IEC 60601-1:2005+AMD1: | ||
| 2012+AMD2:2020(IEC | ||
| 60601-1:2020) | IEC 60601-1:2005+A1:2012 | |
| IEC 60601-1-2:2014+A1:2020 | IEC 60601-1-2:2014 | |
| IEC 60601-2-22:2019 | IEC 60601-2-22:2007+A1:2012 | |
| IEC 60825-1:2014 | IEC 60825-1:2014 |
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Medical Diode Laser and optical fibers. The Medical Diode Laser complies with the IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-2-22:2019 and IEC 60825-1:2014 standards for safety and the IEC 60601-1-2:2014+A1:2020 standard for EMC.
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 and the documentation was provided accordingly.
Summary
Based on the clinical performance, technological characteristics and performance data as documented in the submission, the Medical Diode Laser was found to have a safety and effectiveness profile that is same as the predicate device.
VIII. Conclusions
Based on its technical characteristics, performance test data, and its indications for use as above summary, we conclude that the subject device is as safe and effective as the predicate device.
Animal or clinical studies: None