The Medical Diode Laser (Model: M2-GK) is indicated for use in surgical applications requiring the vaporization. incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: M2-GK) is further indicated for laser assisted lipolysis.

Device Description

The Medical Diode Laser device incorporates a dual wavelength Gallium Aluminum Arsenide (GaAlAs) diode laser for producing its therapeutic effects, it is designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 980mm and 1470nm respectively. The device also incorporates a red (650mm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, foot switch, power cord, and protective goggles. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via third-party optical fibers with SMA905 connectors and with single cores of 200um, 400μm, 600μm, 800μm and 1000um diameter respectively.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Medical Diode Laser, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study for a novel device. The information provided is primarily related to non-clinical bench testing and software verification, not clinical performance or impact on human readers.

Therefore, many of the requested categories for a study proving acceptance criteria will either be "Not Applicable" or the information cannot be found in the provided text.

Here is an analysis based on the provided text:

Acceptance Criteria and Device Performance (Not applicable in this context)

The document does not specify quantitative acceptance criteria for clinical device performance in the way one might expect for a diagnostic or AI-powered device. Instead, the "performance" demonstrated is adherence to electrical safety and performance standards for laser products.

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Clinical Performance	Not applicable. No clinical data provided or required for this 510(k). The device is a surgical laser, and its performance is assessed against established safety and technical standards for such devices, not against specific outcome metrics in patients for substantial equivalence.
Electrical Safety	Conforms to IEC 60601-1:2005+AMD1:2012+AMD2:2020
Electromagnetic Compatibility (EMC)	Conforms to IEC 60601-1-2:2014+A1:2020
Laser Safety (Equipment Classification & Requirements)	Conforms to IEC 60825-1:2014
Laser Safety (Surgical/Cosmetic/Therapeutic/Diagnostic Equipment Specific)	Conforms to IEC 60601-2-22:2019
Accuracy Specifications	"The results of the bench testing show that the subject device meets its accuracy specifications and meets relevant consensus standards." (Specific accuracy metrics not provided)
Software Functionality	Software verification and validation conducted; considered "Basic Documentation Level" and documentation provided. "demonstrate that the device can perform as intended."
Indications for Use (Substantial Equivalence)	"The indications for use of the subject device are nearly the same as those from each of the predicate devices and also do not raise new types of questions regarding safety and effectiveness."
Technology (Substantial Equivalence)	"The subject device uses similar 980nm and 1470mm diode lasers technology as that used by the predicates."
Output Parameters (Substantial Equivalence)	"The output parameters of the proposed device are similar to the output parameters of the predicates, and differences in the output parameters do not raise new types of questions regarding the safety and effectiveness..."

Study Information (Based on the document):

A table of acceptance criteria and the reported device performance:
- See table above. As explained, these are technical and regulatory performance criteria rather than typical clinical acceptance criteria for an AI or diagnostic device.
Sample sizes used for the test set and the data provenance:
- Not applicable. The document states "Clinical data: Not applicable." The "Performance Testing - Bench" refers to laboratory bench testing of the laser's physical parameters and safety, not a test set of patient data. The provenance of such bench testing data would typically be the manufacturer's internal testing facilities, but this detail is not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Not a clinical study. Ground truth in this context would be the calibrated measurement instruments used for technical performance testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Not a clinical study.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states "Clinical data: Not applicable." This device is a surgical laser, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Performance Testing - Bench" and "Software Verification and Validation Testing" are essentially standalone tests of the device's technical functionality and software, without human users interacting in a clinical evaluation sense. The device itself (Medical Diode Laser) operates as a standalone piece of equipment for surgical procedures.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical performance and safety testing is established by international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22) and the accuracy specifications defined by the manufacturer for the device's output parameters. For software, the ground truth is adherence to the validated software requirements.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.
How the ground truth for the training set was established:
- Not applicable. See #8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "Administration".

June 17, 2024

Wuhan Pioon Technology Co.,Ltd. Tracy Liu Regulatory Affairs 7th Floor,A21 of Sino Pharm Building,Biolake Innovation Park No.666 Gaoxin Avenue,East Lake High-tech Development Zone Wuhan, Hubei 430075 China

Re: K240747

Trade/Device Name: Medical Diode Laser (M2-GK) 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: March 12, 2024 Received: March 19, 2024

Dear Tracv 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

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 820.30 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.

Digitally signed Tanisha L. by Tanisha L. Hithe -S Hithe -S Date: 2024.06.17 15:47:05 -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}------------------------------------------------

Indications for Use

510(k) Number (if known) K240747

Device Name Medical Diode Laser (M2-GK)

Indications for Use (Describe)

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

"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."

{4}------------------------------------------------

PIOON

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: K240747

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: June 8, 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: M2-GK 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

3. Predicate Device

G.N.S neoLaser Ltd.,neoV980 & neoV1470 Diode Lasers, Model: neoV980 and neoV1470 - K152722.(Primary Predicate Device)

{5}------------------------------------------------

PRON

Page 2 of 6

Quanta System S.p.A, Quanta System QUANTA Diode Laser Family, Model: QUANTA980 and QUANTA1470 - K100558.(Secondary Predicate Device) The predicates have not been subject to a design-related recall. No reference devices were used in this submission.

Device Description 4.

ર. Indications for Use

The Medical Diode Laser (Model: M2-GK) is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: M2-GK) is further indicated for laser assisted lipolysis.

Comparison to the Predicate Device 6.

The Medical Diode Laser (Model: M2-GK) ,has been compared to the the neoV980 and neoV1470 Diode Laser of G.N.S neoLaser neoV980 & neoV1470 Diode Lasers(K152722),QUANTA980 and QUANTA1470 Diode Lasers of Quanta System QUANTA Diode Laser Family(K100558) as reference for substantial equivalence. A table comparing the predicate devices to the subject device is shown as the following:

Item	Subject Device(this submission)	Primary PredicateDevice(K152722)	Secondary PredicateDevice(K100558)
Product Code	GEX	GEX	GEX
RegulationNO.	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Class	II	II	II
Indicationsfor UseComparisonInformation	The Medical DiodeLaser(Model: M2-GK)is indicated for use insurgical applicationsrequiring thevaporization, incision,excision, ablation,cutting and hemostasis,or coagulation of softtissue in conjunctionwith endoscopicequipment for medicalspecialist including:Urology, ThoracicSurgery, Plastic Surgeryand Dermatology,General Surgery,Ophthalmology,Orthopedics, Podiatry,Arthroscopy, SpinalSurgery, Gynecology,Pulmonary Surgery,Neurosurgery,Gastroenterology,Head/neck/ENT andRadiology, Oral Surgeryand Dental procedures,Endovascularcoagulation andendovenous occlusionof the greater saphenousvein in patients withsuperficial vein reflux.The Medical DiodeLaser(Model: M2-GK)is further indicated forlaser assisted lipolysis.	The neoV980 &neoV1470 Diode Lasers,(and their deliveryaccessories used todeliver optical energy)are indicated for use insurgical applicationsrequiring thevaporization, incision,excision, ablation, cuttingand hemostasis, orcoagulation of soft tissuein conjunction withendoscopic equipmentfor medical specialtiesincluding: Urology,Thoracic Surgery, PlasticSurgery andDermatology, GeneralSurgery, Ophthalmology,Orthopedics, Podiatry,Arthroscopy, SpinalSurgery, Gynecology,Pulmonary Surgery,Neurosurgery,Gastroenterology,Head/neck/ENT andRadiology, Oral Surgeryand Dental procedures,Endovascularcoagulation, andendovenous occlusion ofthe greatest saphenousvein in patients withsuperficial vein reflux.	The Quanta SystemQUANTA Diode LaserFamily, including theQUANTA532,QUANTA808,QUANTA940, QUANTA980,QUANTA1064,QUANTA1320, QUANTA1470,and QUANTA1950 (andall their doublewavelength combinationand their deliveryaccessories used todeliver optical energy)are indicated for use insurgical applicationsrequiring thevaporization, incision,excision, ablation, cuttingand hemostasis, orcoagulation of soft tissuein conjunction withendoscopic equipment formedical specialistincluding: Urology(BPH), Genitourinary(Urology), ThoracicSurgery, Plastic Surgeryand Dermatology,Aesthetics includingvascular lesions and hairremoval, GeneralSurgery, Ophthalmology,Orthopedics, Podiatry,Arthroscopy, SpinalSurgery, Gynecology,Pulmonary Surgery,Neurosurgery(PLDD),Gastroenterology,Head/neck/ENT and
			Radiology, Endovascularcoagulation, Oral Surgeryand Dental procedures.The QUANTA980 andQUANTA1470 DiodeLaser are furtherindicated for laserassisted lipolysis.
Use of Device	Rx only	Rx only	Rx only
Laser Type	Diode laser	Diode laser	Diode laser
LaserClassification	Class IV	Class IV	Class IV
Configuration	Main UnitFoot Control	Main UnitFoot Control	Main UnitFoot Control
Max Power	30W-980nm15W-1470nm	20W-980nm10W-1470nm	30W-980nm15W-1470nm
OperationMode	CW, single pulse, repeatpulse	CW, single pulse, repeatpulse	CW, single pulse, repeatpulse
PulseDuration	10 ms – 1s	100μs-30s	3ms - 2.5s
RepetitionRate	0.5 to 50 Hz	0.02 Hz to 5,000 Hz	1-200Hz
Aiming Beam	Red 650nm (<2mW)	Green 532nm (<5mW)	Red 650nm (<5mW)
CoolingMethod	Air cooling	Air cooling	Air cooling
DeliverySystem	Fiber delivery	Fiber delivery	Fiber delivery
User Interface	Color LCD touch screen	Color LCD touch screen	Color LCD touch screen
Microprocessor Control	Yes	Yes	Yes
Power Supply	100-240VAC, 50/60Hz,4A-2A	100 - 240 V AC, 47/63Hz, 1.06-0.45A	100-240, VAC 50-60 Hz,6.3 A, single phase
Dimensions&Weight	29cm (L) x 25cm (W)x13cm (H)≤8 Kg.	22cm (L) x 22 cm (W) x10 cm (H)3.5 Kg.	39 cm (L) x 33 cm (W) x 25cm (H)8 Kg.

{6}------------------------------------------------

PICON

{7}------------------------------------------------

{8}------------------------------------------------

1

SafetyFeature	Complied with:IEC 60601-1IEC 60601-1-2IEC 60601-2-22IEC 60825-1	Complied with:IEC 60601-1IEC 60601-1-2IEC 60601-2-22IEC 60825-1	Complied with:IEC 60601-1IEC 60601-1-2IEC 60601-2-22IEC 60825-1
-------------------	---------------------------------------------------------------------------------	---------------------------------------------------------------------------------	---------------------------------------------------------------------------------

The subject device uses similar 980nm and 1470mm diode lasers technology as that used by the predicates. The output parameters of the proposed device are similar to the output parameters of the predicates, and differences in the output parameters do not raise new types of questions regarding the safety and effectiveness when the device is used for the proposed indications for use. The indications for use of the subject device are nearly the same as those from each of the predicate devices and also do not raise new types of questions regarding safety and effectiveness.

Performance Data 7.

Clinical data:

Not applicable.

Non-clinical data:

Electrical Compatibility and Electrical Safety

The Medical Diode Laser was tested and found to conform to the criteria of the following performance standards:

· 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

The Guidance Document, Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice 56) January 19, 2018 was used. 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 specifications and meets 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

{9}------------------------------------------------

PIGON

Page 6 of 6

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

The non-clinical data support the safety of the proposed Medical Diode Laser (Model: M2-GK) device, and the software verification and validation demonstrate that the device can perform as intended. The proposed device uses similar laser diode technology as that used by the predicate devices and difference in parameters do not raise new types of questions regarding safety and effectiveness for the proposed indications for use. The Medical Diode Laser (Model: M2-GK) is considered to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.