Who is the manufacturer of Medical Diode Laser (M2-GK)?

Wuhan Pioon Technology Co., Ltd. filed the 510(k) submission for Medical Diode Laser (M2-GK) (K240747).

What is the FDA product code for Medical Diode Laser (M2-GK)?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Medical Diode Laser (M2-GK)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Medical Diode Laser (M2-GK)?

neoV980 & neoV1470 Diode Lasers (K152722); Quanta System QUANTA Diode Laser Family (K100558).

Who can help prepare an FDA 510(k) submission like Medical Diode Laser (M2-GK)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medical Diode Laser (M2-GK)

K240747 · Wuhan Pioon Technology Co., Ltd. · GEX · Jun 17, 2024 · General, Plastic Surgery

Device Facts

Record ID	K240747
Device Name	Medical Diode Laser (M2-GK)
Applicant	Wuhan Pioon Technology Co., Ltd.
Product Code	GEX · General, Plastic Surgery
Decision Date	Jun 17, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Medical Diode Laser (M2-GK) is a surgical laser system delivering continuous or pulsed infrared energy at 980nm and 1470nm wavelengths; incorporates 650nm red aiming beam. System comprises main unit, foot switch, power cord, and protective goggles. User operates via LCD touchscreen to set output parameters. Laser energy is transmitted through third-party optical fibers (SMA905 connectors, 200-1000um diameters). Used by medical specialists in clinical/surgical settings for soft tissue procedures and endovenous occlusion. Device provides precise tissue interaction (vaporization, coagulation, etc.) to facilitate surgical outcomes; benefits include controlled tissue ablation and hemostasis.

Clinical Evidence

No clinical data. Bench testing only. Performance validated through functional and system-level testing against consensus standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.

Technological Characteristics

Dual-wavelength (980nm/1470nm) GaAlAs diode laser; 650nm red aiming beam. Air-cooled. Fiber delivery via SMA905 connectors. LCD touchscreen interface. Microprocessor-controlled. Power: 100-240VAC. Dimensions: 29cm x 25cm x 13cm; weight ≤8kg. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.

Indications for Use

Indicated for surgical soft tissue vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation in various medical specialties including urology, thoracic, plastic, general, ophthalmic, orthopedic, podiatric, arthroscopic, spinal, gynecological, pulmonary, neurosurgery, gastroenterology, ENT, radiology, oral/dental, and endovascular procedures (including endovenous occlusion of greater saphenous vein for superficial vein reflux) and laser-assisted lipolysis.

Regulatory Classification

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.

Predicate Devices

neoV980 & neoV1470 Diode Lasers (K152722)
Quanta System QUANTA Diode Laser Family (K100558)

Related Devices

K250656 — Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) · Wuhan Pioon Technology Co., Ltd. · Apr 4, 2025
K240644 — Medical Diode Laser (S1Pro) · Wuhan Pioon Technology Co., Ltd. · Jun 10, 2024
K240179 — Medical Diode Laser (Model: L2) · Wuhan Pioon Technology Co., Ltd. · Mar 21, 2024
K060304 — PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 · Biotex, Inc. · Mar 21, 2006
K090164 — CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER · Biolitec, Inc. · Jun 26, 2009

Submission Summary (Full Text)

{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) 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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. 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. #### 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 Predicate Device (K152722) | Secondary Predicate Device (K100558) | |-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | GEX | GEX | GEX | | Regulation NO. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | | Class | II | II | II | | Indications for Use Comparison Information | 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, 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. | The neoV980 & neoV1470 Diode Lasers, (and their delivery accessories used to deliver optical energy) are 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 specialties 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 greatest saphenous vein in patients with superficial vein reflux. | The Quanta System QUANTA Diode Laser Family, including the QUANTA532, QUANTA808,QUANTA 940, QUANTA980, QUANTA1064,QUANT A1320, QUANTA1470, and QUANTA1950 (and all their double wavelength combination and their delivery accessories used to deliver optical energy) are 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 (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery(PLDD), Gastroenterology, Head/neck/ENT and | | | | | Radiology, Endovascular coagulation, Oral Surgery and Dental procedures. The QUANTA980 and QUANTA1470 Diode Laser are further indicated for laser assisted lipolysis. | | Use of Device | Rx only | Rx only | Rx only | | Laser Type | Diode laser | Diode laser | Diode laser | | Laser Classification | Class IV | Class IV | Class IV | | Configuration | Main Unit Foot Control | Main Unit Foot Control | Main Unit Foot Control | | Max Power | 30W-980nm 15W-1470nm | 20W-980nm 10W-1470nm | 30W-980nm 15W-1470nm | | Operation Mode | CW, single pulse, repeat pulse | CW, single pulse, repeat pulse | CW, single pulse, repeat pulse | | Pulse Duration | 10 ms – 1s | 100μs-30s | 3ms - 2.5s | | Repetition Rate | 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) | | Cooling Method | Air cooling | Air cooling | Air cooling | | Delivery System | Fiber delivery | Fiber delivery | Fiber delivery | | User Interface | Color LCD touch screen | Color LCD touch screen | Color LCD touch screen | | Microprocess or Control | Yes | Yes | Yes | | Power Supply | 100-240VAC, 50/60Hz, 4A-2A | 100 - 240 V AC, 47/63 Hz, 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) x 10 cm (H) 3.5 Kg. | 39 cm (L) x 33 cm (W) x 25 cm (H) 8 Kg. | {6}------------------------------------------------ # PICON {7}------------------------------------------------ {8}------------------------------------------------ | 1 | | |---|--| | | | | Safety Feature | Complied with: IEC 60601-1 IEC 60601-1-2 IEC 60601-2-22 IEC 60825-1 | Complied with: IEC 60601-1 IEC 60601-1-2 IEC 60601-2-22 IEC 60825-1 | Complied with: IEC 60601-1 IEC 60601-1-2 IEC 60601-2-22 IEC 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.