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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Medical Diode Laser, Model S1Pro, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device and compliance with relevant safety and performance standards. The "reported device performance" refers to the successful verification against these standards.

Acceptance Criteria Category	Standard/Requirement	Reported Device Performance
Safety and Essential Performance	IEC 60601-1:2005+AMD1:2012+AMD2:2020	Complies (assessed for conformity)
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014+A1:2020	Complies (assessed for conformity)
Laser Specific Safety/Performance	IEC 60601-2-22:2019	Complies (assessed for conformity)
Software Verification & Validation	FDA Guidance for software in medical devices (moderate concern level)	Software verification and validation testing conducted, documentation provided, device performs as intended.
General Laser Safety	IEC 60825-1:2014	Complies (assessed for conformity)
Functional & System Level Testing	Accuracy specifications, relevant consensus standards	Meets accuracy specification and relevant consensus standards.
Substantial Equivalence	Same intended use, similar technological characteristics, no new questions of safety/effectiveness compared to predicate.	Demonstrated to be substantially equivalent to predicate K211977.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for functional performance).
Data Provenance: The studies are non-clinical bench tests and software verification and validation testing. There is no mention of human subject data, therefore, no country of origin is applicable in the usual sense for clinical trials. The tests were conducted by Wuhan Pioon Technology Co., Ltd.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies are non-clinical (bench testing, software V&V). Ground truth, in this context, would be defined by the technical specifications and standards (e.g., a laser's output power must be within a certain tolerance as per its design specification and relevant IEC standards).

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical benchmarks against predetermined technical specifications and international standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical data: Not applicable." This is a non-clinical submission for a medical device.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the performance data detailed are primarily standalone in nature. This refers to the device itself performing according to its design specifications and relevant safety/performance standards (electrical safety, EMC, laser safety, functional performance, and software V&V). There is no "algorithm" in the sense of AI/image analysis being evaluated, but rather the functional performance of the laser device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical studies described is:

Technical Specifications: The device's own design specifications for parameters like wavelength, output power, pulse width, aiming beam power, dimensions, etc.
International Consensus Standards: Compliance with standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
FDA Guidance: For software verification and validation, compliance with FDA's guidance for software in medical devices.

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device that requires training data. The "training" of the device is its design and manufacturing to meet specifications.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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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 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.

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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

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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)

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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.

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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
ProprietaryName	Medical Diode LaserSystems	Medical Diode Laser	NA
Model	CHERYLAS-15N;CHERYLAS-20N	S1Pro	NA
Manufacturer	Wuhan Dimed LaserTechnology Co., Ltd.	Wuhan PioonTechnology Co.,Ltd.	NA
Productpicture	Image: Predicate Device	Image: Subject Device	NA
Classificationname	Powered Laser SurgicalInstrument	Powered Laser SurgicalInstrument	Same
Product Code	GEX	GEX	Same
RegulationNumber	21 CFR 878.4810	21 CFR 878.4810	Same
Indications forUse	The "CHERYLAS-15Nand CHERYLAS-20N”are indicated for use in thetreatment of reflux ofthe saphenous veinsassociated with varicoseveins and varicosities.	The Medical DiodeLaser ,Model S1Pro isindicated for use in thetreatment of reflux ofthe saphenous veinsassociated with varicoseveins and varicosities.	Same
Laser Type	diode laser	diode laser	Same
Components	Laser system, Colortouch screen, Footswitch	Laser system, Colortouch screen, Footswitch	Same
Wavelength	1470nm	1470nm	Same
Output power	CHERYLAS-15N:0.1W-15W;CHERYLAS-20N:0.1W-20W;	S1Pro:0-12W	Similar
Operationmode	CW, single pulse, repeatpulse	CW, single pulse, repeatpulse	Same
Pulse width	10ms- 3s	10ms-25s	Different
Pulserepetitionrate	0.2Hz-50Hz	0-50Hz	Similar
Application /Light deliverysystem	It is recommended touse the disposablesterile fiber (K124003,MED-Fibers, Inc.)registered in U.S.A.The parameters mustmeet the followingrequirements:•bare fiber, long as 3m•Fiber core diameter:600μm•NA ≥0.22	It is recommended touse the disposablesterile fiber (K124003,MED-Fibers, Inc.)registered in U.S.A.The parameters mustmeet the followingrequirements:•Fiber corediameter:400μm,600μm•NA ≥0.22	Similar

	• With SMA905connector• Single used	• With SMA905connector• Single used
Aiming Beam	Diode laser of 650nm,power <3mW, adjustablebrightness.	Diode laser of 650nm,power <2mW,adjustablebrightness.	Similar
Laser Class	4	4	Same
Operationinterface	Color LCD touch screen	Color LCD touch screen	Same
Power Supply	100-240VAC, 50/60Hz,1.4A	100-240VAC, 50/60Hz,24VDC, 2.5A Max	Similar
Safetyclassification	ClassI Type B	ClassI Type B	Same
Dimensions	380(W)430(L)220(H)mm	210 (W)210 (L)140(H) mm	Different
Weight	11kg	≤4KG NW	Different
Waterprooflevel	IPX1	IPX0	Different
FootswitchWaterprooflevel	IPX8	IPX8	Same
Standard	IEC60601-1IEC60601-1-2IEC60601-2-22IEC60825-1	IEC60601-1IEC60601-1-2IEC60601-2-22IEC60825-1	Same
Non- sterile	Fiber is sterilized by EO.	Fiber is sterilized byEO.	Same
Microprocessor Control	Yes	Yes	Same

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Image /page/5/Picture/0 description: The image contains the word "PICON" in a stylized font. The first two letters, "PI", are in gray, while the "O" and "N" are in blue. There is a star-like shape in between the "I" and "O". The logo appears to be for a company or organization named PICON.

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Image /page/6/Picture/0 description: The image shows the word "PICOON" in a stylized font. The first three letters, "PIC", are in gray, while the last three letters, "OON", are in blue. The "I" in "PIC" is replaced by a four-pointed star shape, also in gray. The overall design is modern and clean.

The subject device has same intended use, similar product design, same performance effectiveness, and performance safety as the predicate device.

The differences between the subject device and predicate device are minor and both products meet the same standard IEC60601-1, IEC60601-1-2, IEC60601-2-22 and IEC60825-1. The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

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As seen in the comparison tables, the subject and predicate device have the same intended use and similar technological characteristics. The main technological differences between the subject and predicate device are minor differences, and do not raise different questions of safety or effectiveness. Information contained in this submission demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the subject device is substantially equivalent to the predicate device.

Performance Data 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.

Conclusions 8.

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PICON

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. In other words, the subject device Medical Diode Laser Systems (Model: S1Pro) is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.