Medical Diode Laser (S1Pro)
Device Facts
| Record ID | K240644 |
|---|---|
| Device Name | Medical Diode Laser (S1Pro) |
| Applicant | Wuhan Pioon Technology Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Jun 10, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Medical Diode Laser (Model: S1Pro) 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, Headineck/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: S1Pro) is further indicated for laser assisted lipolysis.
Device Story
Medical Diode Laser (S1Pro) is a powered surgical laser system; utilizes 1470nm GaAlAs diode laser for soft tissue therapeutic effects; includes 650nm red aiming beam. System comprises main unit, foot switch, power cord, and protective goggles. User interface features LCD touchscreen for parameter control. Laser energy delivered via third-party optical fibers (400um/600um diameter) with SMA905 connectors. Operated by medical specialists in clinical settings. Device provides precise tissue interaction for incision, ablation, and coagulation; benefits include controlled surgical outcomes and minimally invasive access for endovenous and lipolysis procedures.
Clinical Evidence
No clinical data. Substantial equivalence established via bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-2), laser safety (IEC 60825-1), and performance testing (IEC 60601-2-22).
Technological Characteristics
1470nm GaAlAs diode laser; 650nm red aiming beam; air-cooled; microprocessor-controlled; LCD touchscreen interface; SMA905 fiber optic connectivity. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1. Class II, Product Code GEX.
Indications for Use
Indicated for surgical soft tissue applications (vaporization, incision, excision, ablation, cutting, hemostasis, coagulation) in various medical specialties including urology, thoracic, plastic, dermatology, general, ophthalmology, orthopedics, podiatry, arthroscopy, spinal, gynecology, pulmonary, neurosurgery, gastroenterology, ENT, radiology, oral/dental, and endovascular procedures (saphenous vein occlusion). Also indicated for 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, Model: neoV1470 (K152722)
- Quanta System QUANTA Diode Laser Family, Model: QUANTA1470 (K100558)
Reference Devices
- Medical Diode Laser, Model: S1Pro (K231548)
Submission Summary (Full Text)
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June 10, 2024
Wuhan Pioon Technology Co.,Ltd. Tracv Liu Regulatory Affairs 7th Floor,A21 of Sino Pharm Building, Biolake Innovation Park, No.666 Gaoxin Avenue, East Lake High-tech Development Wuhan, Hubei 430075 China
Re: K240644
Trade/Device Name: Medical Diode Laser (S1Pro) 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 7, 2024 Received: March 7, 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 (the 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/cdrh/ofdocs/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.
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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 (OS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
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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. Digitally signed by Digitally signed by Hithe -S______________________________________________________________________________________________________________________________________________________________________ 17:50:53 -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
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# Indications for Use
510(k) Number (if known) K240644
Device Name Medical Diode Laser (S1Pro)
### Indications for Use (Describe)
The Medical Diode Laser (Model: S1Pro) 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, Headineck/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: S1Pro) is further indicated for laser assisted lipolysis.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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PIQON
# 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: K240644
# 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, PEOPLE'S REPUBLIC OF CHINA Tel: +86 27 81783687
Contact Person: Zhang Feng, Official Primary Correspondent and Management Representative Phone: +86 18062448535 E-mail: zhangfeng@pioon.com
Date Prepared: 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: S1Pro 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 and Reference Device
Predicate Device: G.N.S neoLaser Ltd.,neoV980 & neoV1470 Diode Lasers, Model: neoV1470 -K152722.(Primary Predicate Device)
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Quanta System S.p.A, Quanta System QUANTA Diode Laser Family, Model: QUANTA1470 - K100558.(Secondary Predicate Device) Reference Device: Wuhan Pioon Technology Co.,Ltd., Medical Diode Laser, Model: S1Pro - K231548.
#### Device Description 4.
The Medical Diode Laser device incorporates a 1470nm wavelength Gallium Aluminum Arsenide (GaAlAs) diode laser for producing its therapeutic effects. The device also incorporates a red (650nm) 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 transmits the laser output via third-party optical fibers with SMA905 connectors and with single cores of 400um and 600um diameter respectively.
#### Indications for Use న్.
The Medical Diode Laser (Model: S1Pro) 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: S1Pro) is further indicated for laser assisted lipolysis.
#### Comparison to the Predicate Device 6.
The Medical Diode Laser(Model: S1Pro) has been compared to the neoV1470 Diode Laser of G.N.S neoLaser neoV980 & neoV1470 Diode Lasers(K152722) and QUANTA 1470 Diode Laser 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<br>(this submission) | Primary Predicate<br>Device<br>(K152722) | Secondary Predicate<br>Device<br>(K100558) |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Item | Subject Device<br>(this submission) | Primary Predicate<br>Device<br>(K152722) | Secondary Predicate<br>Device<br>(K100558) |
| Product Code | GEX | GEX | GEX |
| Regulatory<br>Class | Class II | Class II | Class II |
| Proprietary<br>Name | Medical Diode Laser | neoV980 & neoV1470<br>Diode Lasers | Quanta System<br>QUANTA Diode Laser<br>Family |
| Model | S1Pro | neoV1470 | QUANTA1470 |
| Manufacturer | Wuhan Pioon<br>Technology Co.,Ltd. | G.N.S neoLaser Ltd. | Quanta System S.p.A |
| Indications<br>for Use<br>Comparison<br>Information | The Medical Diode<br>Laser(Model: S1Pro) is<br>indicated for use in<br>surgical applications<br>requiring the<br>vaporization, incision,<br>excision, ablation,<br>cutting and hemostasis,<br>or coagulation of soft<br>tissue in conjunction<br>with endoscopic<br>equipment for medical<br>specialist including:<br>Urology, Thoracic<br>Surgery, Plastic Surgery<br>and Dermatology,<br>General Surgery,<br>Ophthalmology,<br>Orthopedics, Podiatry,<br>Arthroscopy, Spinal<br>Surgery, Gynecology,<br>Pulmonary Surgery,<br>Neurosurgery,<br>Gastroenterology,<br>Head/neck/ENT and<br>Radiology, Oral Surgery<br>and Dental procedures,<br>Endovascular<br>coagulation and<br>endovenous occlusion of<br>the greater saphenous<br>vein in patients with | The neoV980 &<br>neoV1470 Diode<br>Lasers, (and their<br>delivery accessories<br>used to deliver optical<br>energy) are indicated for<br>use in surgical<br>applications requiring<br>the vaporization,<br>incision, excision,<br>ablation, cutting and<br>hemostasis, or<br>coagulation of soft<br>tissue in conjunction<br>with endoscopic<br>equipment for medical<br>specialties including:<br>Urology, Thoracic<br>Surgery, Plastic Surgery<br>and Dermatology,<br>General Surgery,<br>Ophthalmology,<br>Orthopedics, Podiatry,<br>Arthroscopy, Spinal<br>Surgery, Gynecology,<br>Pulmonary Surgery,<br>Neurosurgery,<br>Gastroenterology,<br>Head/neck/ENT and<br>Radiology, Oral Surgery<br>and Dental procedures,<br>Endovascular | The Quanta System<br>QUANTA Diode Laser<br>Family, including the<br>QUANTA532,<br>QUANTA808,QUANT<br>A940, QUANTA980,<br>QUANTA1064,QUAN<br>TA1320,<br>QUANTA1470, and<br>QUANTA1950 (and all<br>their double wavelength<br>combination and their<br>delivery accessories<br>used to deliver optical<br>energy) are indicated for<br>use in surgical<br>applications requiring<br>the vaporization,<br>incision, excision,<br>ablation, cutting and<br>hemostasis, or<br>coagulation of soft<br>tissue in conjunction<br>with endoscopic<br>equipment for medical<br>specialist including:<br>Urology (BPH),<br>Genitourinary<br>(Urology), Thoracic<br>Surgery, Plastic Surgery<br>and Dermatology,<br>Aesthetics including |
| Item | Subject Device<br>(this submission) | Primary Predicate<br>Device<br>(K152722) | Secondary Predicate<br>Device<br>(K100558) |
| | superficial vein reflux. | coagulation, and<br>endovenous occlusion<br>of the greatest<br>saphenous vein in<br>patients with superficial<br>vein reflux. | vascular lesions and hair<br>removal, General<br>Surgery,<br>Ophthalmology,<br>Orthopedics, Podiatry,<br>Arthroscopy , Spinal<br>Surgery, Gynecology,<br>Pulmonary Surgery,<br>Neurosurgery(PLDD),<br>Gastroenterology,<br>Head/neck/ENT and<br>Radiology,<br>Endovascular<br>coagulation, Oral<br>Surgery and Dental<br>procedures. |
| | The Medical Diode<br>Laser(Model: S1Pro) is<br>further indicated for<br>laser assisted lipolysis. | NA | The QUANTA980 and<br>QUANTA1470 Diode<br>Laser are further<br>indicated for laser<br>assisted lipolysis. |
| Use of device | Rx only | Rx only | Rx only |
| Laser Type | diode laser | diode laser | diode laser |
| Laser Class | 4 | 4 | 4 |
| Components | Laser system, Color<br>touch screen, Foot<br>switch | Laser system, Color<br>touch screen, Foot<br>switch | Laser system, Color<br>touch screen, Foot<br>switch |
| Wavelength | 1470nm | 1470nm | 1470nm |
| Max Output<br>Power | 12W | 10W | 15W |
| Operation<br>Mode | CW, single pulse, repeat<br>pulse | CW, single pulse, repeat<br>pulse | CW, single pulse, repeat<br>pulse |
| Pulse<br>Duration | 10ms-25s | 100μs-30s | 3ms - 2.5s |
| Repetition<br>Rate | 0-50Hz | 0.02 Hz to 5,000 Hz | 1-200Hz |
| Aiming Beam | Diode laser of 650nm,<br>power <2mW,<br>adjustable brightness. | Green (532nm),<br>adjustable - <5mW | Red (650nm), adjustable<br>- <5mW |
| Item | Subject Device<br>(this submission) | Primary Predicate<br>Device<br>(K152722) | Secondary Predicate<br>Device<br>(K100558) |
| Operation<br>Interface | Color LCD touch screen | Color LCD touch screen | Color LCD touch screen |
| Power Supply | 100-240VAC, 50/60Hz,<br>2.5A Max | 100 - 240 V AC, 47/63<br>Hz, 1.06-0.45A | 100-240, VAC 50-60<br>Hz, 6.3 A, single phase |
| Dimensions&<br>Weight | 210 (L)* 210 (W)*<br>140(H) mm<br><=4KG NW | 22cm (L) x 22 cm (W) x<br>10 cm (H)<br>3.5 Kg. | 39 cm (L) x 33 cm (W)<br>x 25 cm (H)<br>8 Kg. |
| Cooling<br>Method | Air cooling | Air cooling | Air cooling |
| Microprocess<br>or Control | Yes | Yes | Yes |
| Standard | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-22<br>IEC60825-1 | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-22<br>IEC60825-1 | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-22<br>IEC60825-1 |
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PICON
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PICON
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PIOON
The subject device uses similar 1470mm diode laser 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.
# 7. Performance Data
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
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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 specificatio…
