(95 days)
No
The description focuses on the laser technology, aiming beam, user interface (LCD touchscreen), and physical components. There is no mention of AI, ML, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration in medical devices.
Yes
The device is used for surgical applications like vaporization, incision, excision, ablation, cutting, and hemostasis, as well as laser-assisted lipolysis, all of which are considered therapeutic effects.
No
The device is described as a medical diode laser used for surgical applications requiring vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue, and laser-assisted lipolysis. These are therapeutic, not diagnostic, functions.
No
The device description explicitly lists hardware components such as a main unit, foot switch, power cord, and protective goggles, and describes a physical laser mechanism.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical applications requiring the vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The device description details a laser system designed to deliver energy to tissue. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
In summary, the Medical Diode Laser (Model: S1Pro) is a therapeutic device used for surgical procedures, not a diagnostic device used for analyzing biological samples.
N/A
Intended Use / 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, 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.
Product codes
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue; greater saphenous vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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, conforming to IEC 60825-1:2014 and IEC 60601-2-22:2019. The results of the bench testing show that the subject device meets its accuracy specifications and meets relevant consensus standards.
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."
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.
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 (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).
2
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. 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)
5
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
(this submission) | Primary Predicate
Device
(K152722) | Secondary Predicate
Device
(K100558) |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Item | Subject Device
(this submission) | Primary Predicate
Device
(K152722) | Secondary Predicate
Device
(K100558) |
| Product Code | GEX | GEX | GEX |
| Regulatory
Class | Class II | Class II | Class II |
| Proprietary
Name | Medical Diode Laser | neoV980 & neoV1470
Diode Lasers | Quanta System
QUANTA Diode Laser
Family |
| Model | S1Pro | neoV1470 | QUANTA1470 |
| Manufacturer | Wuhan Pioon
Technology Co.,Ltd. | G.N.S neoLaser Ltd. | Quanta System S.p.A |
| Indications
for Use
Comparison
Information | 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 | 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 | The Quanta System
QUANTA Diode Laser
Family, including the
QUANTA532,
QUANTA808,QUANT
A940, QUANTA980,
QUANTA1064,QUAN
TA1320,
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 |
| Item | Subject Device
(this submission) | Primary Predicate
Device
(K152722) | Secondary Predicate
Device
(K100558) |
| | superficial vein reflux. | coagulation, and
endovenous occlusion
of the greatest
saphenous vein in
patients with superficial
vein reflux. | 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 Medical Diode
Laser(Model: S1Pro) is
further indicated for
laser assisted lipolysis. | NA | 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 Class | 4 | 4 | 4 |
| Components | Laser system, Color
touch screen, Foot
switch | Laser system, Color
touch screen, Foot
switch | Laser system, Color
touch screen, Foot
switch |
| Wavelength | 1470nm | 1470nm | 1470nm |
| Max Output
Power | 12W | 10W | 15W |
| Operation
Mode | CW, single pulse, repeat
pulse | CW, single pulse, repeat
pulse | CW, single pulse, repeat
pulse |
| Pulse
Duration | 10ms-25s | 100μs-30s | 3ms - 2.5s |
| Repetition
Rate | 0-50Hz | 0.02 Hz to 5,000 Hz | 1-200Hz |
| Aiming Beam | Diode laser of 650nm,
power