(58 days)
Not Found
No
The description focuses on the laser technology, hardware components, and standard electrical/performance testing. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is intended for medical procedures such as incision, excision, ablation, vaporization, hemostasis, and coagulation of soft tissue, as well as endovascular coagulation and occlusion of the greatest saphenous vein, which are all therapeutic interventions.
No
The device is indicated for surgical procedures (incision, excision, ablation, vaporization, hemostasis, coagulation, occlusion) of soft tissue and veins, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a "compact diode laser" composed of a "main unit, foot switch, power cord and protective goggles," indicating it is a hardware device. While it includes software for user control, it is not solely software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a Medical Diode Laser used for surgical procedures like incision, excision, ablation, vaporization, hemostasis, coagulation, and endovenous occlusion. These are all procedures performed on the body, not on samples taken from the body.
- Intended Use: The intended use describes surgical interventions on soft tissue and veins, not diagnostic testing of biological samples.
Therefore, the Medical Diode Laser (Model: L2) is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medical Diode Laser (Model: L2) is indicated for:
- -Incision, excision, ablation, vaporization, hemostasis and/or coaqulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
Product codes
GEX
Device Description
The Medical Diode Laser use a wavelength 1470nm 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: L2) 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 included 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
Not Found
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 data was collected for Electrical Compatibility and Electrical Safety, Performance Testing - Bench, and Software Verification and Validation Testing.
Electrical Compatibility and Electrical Safety: The Medical Diode Laser and optical fibers were assessed for conformity with the relevant requirements of the following standards and found to comply: IEC 60601-1:2005+AMD1:2012+AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2:2014+A1:2020 (Fourth Edition) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
Performance Testing - Bench: Pioon has conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards. 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
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, "Content of Premarket Submissions for Device Software Function". The recommended Documentation Level for software of this device was considered as a "Basic Documentation Level " and the documentation was provided accordingly.
All data demonstrated that the subject device performed comparably to the predicate device.
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.
0
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2024
Wuhan Pioon Technology Co., Ltd. Tracy Liu Regulatory Affairs 7th Floor, A21 of Sino Pharm Bldg, Biolake Innovation Park, No.666 Gaoxin Avenue,East Lake High-tech Development Zone Wuhan, hubei 430075 China
Re: K240179
Trade/Device Name: Medical Diode Laser (Model: L2) 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 23, 2024 Received: January 23, 2024
Dear Tracy Liu:
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 (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.
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
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 OS 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.
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.
For comprehensive regulatory information about mediation-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).
2
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/deviceadvice-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. Tanisha L. Hithe -Hithe -S 2024.03.21 12:37:28 -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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
Medical Diode Laser (Model: L2)
Indications for Use (Describe)
The Medical Diode Laser (Model: L2) is indicated for:
- -Incision, excision, ablation, vaporization, hemostasis and/or coaqulation of soft tissue -Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
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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510(k) Summary
In accordance with the content and format regulatory requirements of 21 CFR Part 807.92,the 510(k) Summary for the Medical Diode Laser is provided below.
The assigned 510(k) Number: K240179
1. Submitter
Device Submitter: Wuhan Pioon Technology Co.,Ltd. Address:7th Floor, A21 of Sino Pharm Building, Biolake Innovation Park, No.666 Gaoxin Avenue, East Lake High-tech Development Zone,430075, Wuhan, Hubei, China Tel: +86 27 81783687 Contact Person: Zhang Feng,Management Representative Phone: +86 18062448535
E-mail: zhangfeng@pioon.com
Date Prepared: January 23, 2024
Official Correspondent: Tracy Liu, Wuhan Pioon Technology Co.,Ltd. Phone: +86 15012997429 Email: tracy@pioon.com
2. Device
Type of 510(k) submission: Traditional Device name: Medical Diode Laser Model: L2 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
Predicate Device 3.
Fotona SkyPulse Laser Platform (K193656), 1470nm Diode Laser. This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
5
4. Device Description
The Medical Diode Laser use a wavelength 1470nm 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: L2) 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 included in this device. The device accepts a fiber with single core of 400um and 600um in diameter and with SMA905 connectors.
Indications for Use న.
The Medical Diode Laser (Model: L2) is indicated for:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue -Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
Comparison to the Predicate Device 6.
The Medical Diode Laser (Model: L2) ,has been compared to the 1470 nm Diode Laser Module of Fotona SkyPulse Laser Platform(K193656) as reference for substantial equivalence. A table comparing the predicate device to the subject device is shown as the following:
| Item | Subject device
(this submission) | Predicated device
(K193656) | Comparison
Result |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Product Code | GEX | GEX | Same |
| Regulation
NO. | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | II | II | Same |
| Indications for
use | The Medical Diode Laser
(Model: L2) is indicated
for:
-Incision, excision,
ablation, vaporization,
hemostasis and/or
coagulation of soft tissue
-Endovascular coagulation
and endovenous occlusion
of the greatest saphenous | 1470 nm Diode Laser:
-Incision, excision,
ablation, vaporization,
hemostasis and/or
coagulation of soft tissue
-Endovascular
coagulation and
endovenous occlusion
of the greatest | Same |
| | vein in patients with
superficial vein
reflux | saphenous vein in
patients with superficial
vein
reflux | |
| Use of device | Rx only | Rx only | Same |
| Energy source | Solid state diode | Solid state diode | Same |
| Configuration | Main Unit
Foot Control | Main Unit
Foot Control | Same |
| Laser
Wavelength | 1470nm | 1470nm | Same |
| Laser
Classification | Class IV | Class IV | Same |
| Power range | Up to 20W | Up to 22W | Similar(
Within the
range
of the
predicate) |
| Pulse width | CW or 10 ms – 10 s | CW or 10 ms – 10 s | Same |
| Repetition
rate | CW or up to 100 Hz | CW or up to 100 Hz | Same |
| Delivery
system | Fiber delivery | Fiber delivery | Same |
| User interface | Touch screen control | Touch screen control | Same |
| Safety feature | Complied with:
IEC
60601-1:2005+AMD1:
2012+AMD2:2020(IEC
60601-1:2020)
IEC
60601-1-2:2014+A1:2020
IEC 60601-2-22:2019
IEC 60825-1:2014 | Complied with:
IEC
60601-1:2005+A1:2012
IEC 60601-1-2:2014
IEC
60601-2-22:2007+A1:2
012
IEC 60825-1:2014 | Same |
6
The subject device has same intended use, similar product design, same performance effectiveness, and performance safety as the predicate device.
The differences between the subject device and predicate device are minor and both products meet the same standard IEC60601-1, IEC60601-1-2, IEC60601-2-22 and IEC60825-1. The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
7
As seen in the comparison tables, the subject and predicate device have the same intended use and similar technological characteristics. The main technological differences between the subject and predicate device are minor differences, and do not raise different questions of safety or effectiveness. Information contained in this submission demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness.
Thus, the subject device is substantially equivalent to the predicate device.
7. Performance Data
Clinical data:
Not applicable.
Non-clinical data:
Electrical Compatibility and Electrical Safety
The Medical Diode Laser and optical fibers were assessed for conformity with the relevant requirements of the following standards and found to comply:
· IEC 60601-1:2005+AMD1:2012+AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• IEC 60601-1-2:2014+A1:2020 (Fourth Edition) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
Performance Testing - Bench
Pioon has conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
• 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
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, "Content of Premarket Submissions for Device Software Function".
The recommended Documentation Level for software of this device was considered as a "Basic Documentation Level " and the documentation was provided accordingly.
8. Conclusions
8
The non-clinical data support the safety of the device and the software verification and validation demonstrate that the Medical Diode Laser (Model: L2) device should perform as intended in the specified use conditions, and all the data demonstrate that the subject device perform comparably to the predicate device that is currently marketed for the similar intended use. In other words, the subject device Medical Diode Laser (Model: L2) is substantially equivalent to the predicate device.