(65 days)
No
The summary describes a standard diode laser device with a touchscreen interface and mentions software verification and validation, but there is no mention of AI or ML capabilities, image processing, or data sets for training/testing.
Yes
The intended use clearly states that the device is indicated for the treatment of saphenous veins associated with varicose veins and varicosities, which is a therapeutic purpose.
No
The device is indicated for the treatment of saphenous veins, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists hardware components such as a laser source, aiming beam diode, LCD touchscreen, main unit, foot switch, power cord, and protective goggles. It also mentions accepting a fiber delivery system, although not included. This indicates it is a physical medical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of the saphenous veins associated with varicose veins and varicosities." This is a therapeutic use, directly treating a condition within the patient's body.
- Device Description: The device is a laser used to deliver energy for treatment. It does not involve testing samples of biological material (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample handling, or analysis of biological specimens.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is used for direct therapeutic intervention.
N/A
Intended Use / Indications for Use
The Medical Diode Laser ,Model S1Pro is indicated for the treatment of the saphenous veins associated with varicose veins and varicosities.
Product codes
GEX
Device Description
The Medical Diode Laser use a wavelength 1470nm Galium Aluminum Arsenide (GaAlAs) diode laser as the beam source. The laser utilizes a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The Medical Diode Laser (model: S1Pro) is a compact diode laser with a LCD touchscreen for user control. The device is composed of main unit, foot switch, power cord and protective goggles. The fiber delivery system is not include in this device. The device accepts a fiber with single core of 400μm and 600um in diameter and with SMA905 connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
saphenous veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 and optical fibers were assessed for conformity with the relevant requirements of the following standards and found to comply:
- 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 - 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 specification and meet relevant consensus standards.
- 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
- IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification, and requirements
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, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern and the documentation was provided accordingly.
The non-clinical data support the safety of the device and the software verification and validation demonstrate that the Medical Diode Laser Systems (Model: S1Pro) device should perform as intended in the specified use conditions, and all the data demonstrate that the subject device perform comparably to the predicate device that is currently marketed for the similar intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
August 3, 2023
Wuhan Pioon Technology Co., Ltd. % Valerie Followell Senior RA & QA Consultant Lean RAQA 131 E Loch Lomond Dr Oro Valley, Arizona 85737
Re: K231548
Trade/Device Name: Meical Diode Laser, Model 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: May 30, 2023 Received: May 30, 2023
Dear Valerie Followell:
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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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). 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-device-advice-comprehensive-regulatoryassistance/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.
Jianting Wang -S
Jianting Wang Acting 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231548
Device Name Medical Diode Laser ,Model S1Pro
Indications for Use (Describe)
The Medical Diode Laser ,Model S1Pro is indicated for the treatment of the saphenous veins associated with varicose veins and varicosities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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: K231548
Submitter 1.
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: July 14, 2023
Official Correspondent: Valerie Followell, LeanRAQA Consulting Phone: 847-400-6187 Email:followell(@leanraqa.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
Wuhan Dimed Laser Technology Co., Ltd. Medical Diode Laser Systems, Model: CHERYLAS-15N,CHERYLAS-20N - K211977.
Device Description 4.
The Medical Diode Laser use a wavelength 1470nm Galium Aluminum Arsenide (GaAlAs) diode laser as the beam source. The laser utilizes a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser
4
beam. The Medical Diode Laser (model: S1Pro) is a compact diode laser with a LCD touchscreen for user control. The device is composed of main unit, foot switch, power cord and protective goggles. The fiber delivery system is not include in this device. The device accepts a fiber with single core of 400μm and 600um in diameter and with SMA905 connectors.
5. Indications for Use
The Medical Diode Laser ,Model S1Pro is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Comparison to the Predicate Device 6.
The Medical Diode Laser Systems ,S1Pro has been compared to the Medical Diode Laser Systems ,CHERYLAS-15N and CHERYLAS-20N- K211977 as reference for substantial equivalence. A table comparing the predicate device to the subject device is shown as the following:
| Item | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| 510(k) | |||
| Number | K211977 | NA | NA |
| Product Code | GEX | GEX | Same |
| Proprietary | |||
| Name | Medical Diode Laser | ||
| Systems | Medical Diode Laser | NA | |
| Model | CHERYLAS-15N; | ||
| CHERYLAS-20N | S1Pro | NA | |
| Manufacturer | Wuhan Dimed Laser | ||
| Technology Co., Ltd. | Wuhan Pioon | ||
| Technology Co.,Ltd. | NA | ||
| Product | |||
| picture | Image: Predicate Device | Image: Subject Device | NA |
| Classification | |||
| name | Powered Laser Surgical | ||
| Instrument | Powered Laser Surgical | ||
| Instrument | Same | ||
| Product Code | GEX | GEX | Same |
| Regulation | |||
| Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Indications for | |||
| Use | The "CHERYLAS-15N | ||
| and CHERYLAS-20N” | |||
| are indicated for use in the | |||
| treatment of reflux of | |||
| the saphenous veins | |||
| associated with varicose | |||
| veins and varicosities. | The Medical Diode | ||
| Laser ,Model S1Pro is | |||
| indicated for use in the | |||
| treatment of reflux of | |||
| the saphenous veins | |||
| associated with varicose | |||
| veins and varicosities. | Same | ||
| Laser Type | diode laser | diode laser | Same |
| Components | Laser system, Color | ||
| touch screen, Foot | |||
| switch | Laser system, Color | ||
| touch screen, Foot | |||
| switch | Same | ||
| Wavelength | 1470nm | 1470nm | Same |
| Output power | CHERYLAS-15N: | ||
| 0.1W-15W; | |||
| CHERYLAS-20N: | |||
| 0.1W-20W; | S1Pro: | ||
| 0-12W | Similar | ||
| Operation | |||
| mode | CW, single pulse, repeat | ||
| pulse | CW, single pulse, repeat | ||
| pulse | Same | ||
| Pulse width | 10ms- 3s | 10ms-25s | Different |
| Pulse | |||
| repetition | |||
| rate | 0.2Hz-50Hz | 0-50Hz | Similar |
| Application / | |||
| Light delivery | |||
| system | It is recommended to | ||
| use the disposable | |||
| sterile fiber (K124003, | |||
| MED-Fibers, Inc.) | |||
| registered in U.S.A. | |||
| The parameters must | |||
| meet the following | |||
| requirements: | |||
| •bare fiber, long as 3m | |||
| •Fiber core diameter: | |||
| 600μm | |||
| •NA ≥0.22 | It is recommended to | ||
| use the disposable | |||
| sterile fiber (K124003, | |||
| MED-Fibers, Inc.) | |||
| registered in U.S.A. | |||
| The parameters must | |||
| meet the following | |||
| requirements: | |||
| •Fiber core | |||
| diameter:400μm, | |||
| 600μm | |||
| •NA ≥0.22 | Similar | ||
| • With SMA905 | |||
| connector | |||
| • Single used | • With SMA905 | ||
| connector | |||
| • Single used | |||
| Aiming Beam | Diode laser of 650nm, | ||
| power |