(90 days)
Not Found
No
The document describes a standard diode laser device with user-controlled parameters via a touchscreen. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes
The device description states it is "designed to deliver continuous or pulsed, infrared laser energy for producing its therapeutic effects," and the intended use describes numerous medical treatments.
No
The device is indicated for surgical applications that involve vaporization, incision, excision, ablation, cutting, hemostasis, and coagulation of soft tissue, as well as laser-assisted lipolysis. These are therapeutic, not diagnostic, actions.
No
The device description explicitly details hardware components such as a dual wavelength diode laser, aiming beam diode, main unit, foot switch, power cord, protective goggles, and an LCD touchscreen. It also mentions transmitting laser output via optical fibers. This is clearly a hardware-based medical device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical applications involving the direct interaction with soft tissue for procedures like vaporization, incision, excision, etc. This is a therapeutic device used on the patient, not a diagnostic device used to test samples from the patient.
- Device Description: The description details a laser device designed to deliver energy to tissue via optical fibers. This aligns with a surgical/therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly treat tissue.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
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
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
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)
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 IEC 60601-1:2005+AMD1:2012+AMD2:2020 and IEC 60601-1-2:2014+A1:2020.
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 specifications and meets relevant consensus standards (IEC 60825-1:2014 and IEC 60601-2-22:2019).
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 (