Medical Diode Laser, Model S1Pro
Device Facts
| Record ID | K231548 |
|---|---|
| Device Name | Medical Diode Laser, Model S1Pro |
| Applicant | Wuhan Pioon Technology Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Aug 3, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Medical Diode Laser ,Model S1Pro is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Device Story
Compact diode laser system (1470nm GaAlAs) for surgical treatment of saphenous vein reflux; utilizes 650nm red aiming beam. Device comprises main unit, footswitch, power cord, and protective goggles; requires external disposable sterile fiber (400μm or 600μm core, SMA905 connector). Operated by physician via LCD touchscreen; delivers laser energy in CW, single pulse, or repeat pulse modes. Energy delivery via fiber induces thermal effect on vein tissue to treat varicosities. Used in clinical settings. Output power 0-12W; pulse width 10ms-25s; repetition rate 0-50Hz. Benefits include minimally invasive treatment of venous reflux.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, electrical safety, and electromagnetic compatibility testing per IEC standards.
Technological Characteristics
1470nm GaAlAs diode laser; 650nm aiming beam. Compact form factor (210x210x140mm, ≤4kg). Powered by 100-240VAC/24VDC. Microprocessor-controlled with LCD touchscreen interface. Fiber delivery system (not included) requires SMA905 connector, 400/600μm core, NA ≥0.22. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1. Class 4 laser.
Indications for Use
Indicated for treatment of reflux of saphenous veins associated with varicose veins and varicosities in adult patients.
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
- Wuhan Dimed Laser Technology Co., Ltd. Medical Diode Laser Systems, Model: CHERYLAS-15N, CHERYLAS-20N (K211977)
Reference Devices
- Disposable sterile fiber (K124003, MED-Fibers, Inc.)
Related Devices
- K252564 — Medical Diode Laser Systems (VeinCure) · Baoding Te'Anzhou Electronic Technology Co., Ltd. · Nov 7, 2025
- K160549 — MEDICAL DIODE LASER SYSTEMS · Wuhan Gigaa Optronics Technology Co., Ltd. · Apr 7, 2017
- K211977 — Medical Diode Laser Systems · Wuhan Dimed Laser Technology Co., Ltd. · Oct 26, 2021
- K110225 — ANGIODYNAMICS, INC. VENACURE 1470 LASER · AngioDynamics, Inc. · May 13, 2011
- K082225 — 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 · Biolitec, Inc. · Dec 3, 2008
Submission Summary (Full Text)
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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) | |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">☐</span> 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.
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
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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)<br>Number | K211977 | NA | NA |
| Product Code | GEX | GEX | Same |
| Proprietary<br>Name | Medical Diode Laser<br>Systems | Medical Diode Laser | NA |
| Model | CHERYLAS-15N;<br>CHERYLAS-20N | S1Pro | NA |
| Manufacturer | Wuhan Dimed Laser<br>Technology Co., Ltd. | Wuhan Pioon<br>Technology Co.,Ltd. | NA |
| Product<br>picture | Image: Predicate Device | Image: Subject Device | NA |
| Classification<br>name | Powered Laser Surgical<br>Instrument | Powered Laser Surgical<br>Instrument | Same |
| Product Code | GEX | GEX | Same |
| Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Indications for<br>Use | The "CHERYLAS-15N<br>and CHERYLAS-20N”<br>are indicated for use in the<br>treatment of reflux of<br>the saphenous veins<br>associated with varicose<br>veins and varicosities. | The Medical Diode<br>Laser ,Model S1Pro is<br>indicated for use in the<br>treatment of reflux of<br>the saphenous veins<br>associated with varicose<br>veins and varicosities. | Same |
| Laser Type | diode laser | diode laser | Same |
| Components | Laser system, Color<br>touch screen, Foot<br>switch | Laser system, Color<br>touch screen, Foot<br>switch | Same |
| Wavelength | 1470nm | 1470nm | Same |
| Output power | CHERYLAS-15N:<br>0.1W-15W;<br>CHERYLAS-20N:<br>0.1W-20W; | S1Pro:<br>0-12W | Similar |
| Operation<br>mode | CW, single pulse, repeat<br>pulse | CW, single pulse, repeat<br>pulse | Same |
| Pulse width | 10ms- 3s | 10ms-25s | Different |
| Pulse<br>repetition<br>rate | 0.2Hz-50Hz | 0-50Hz | Similar |
| Application /<br>Light delivery<br>system | It is recommended to<br>use the disposable<br>sterile fiber (K124003,<br>MED-Fibers, Inc.)<br>registered in U.S.A.<br>The parameters must<br>meet the following<br>requirements:<br>•bare fiber, long as 3m<br>•Fiber core diameter:<br>600μm<br>•NA ≥0.22 | It is recommended to<br>use the disposable<br>sterile fiber (K124003,<br>MED-Fibers, Inc.)<br>registered in U.S.A.<br>The parameters must<br>meet the following<br>requirements:<br>•Fiber core<br>diameter:400μm,<br>600μm<br>•NA ≥0.22 | Similar |
| | | | |
| | • With SMA905<br>connector<br>• Single used | • With SMA905<br>connector<br>• Single used | |
| Aiming Beam | Diode laser of 650nm,<br>power <3mW, adjustable<br>brightness. | Diode laser of 650nm,<br>power <2mW,<br>adjustable<br>brightness. | Similar |
| Laser Class | 4 | 4 | Same |
| Operation<br>interface | Color LCD touch screen | Color LCD touch screen | Same |
| Power Supply | 100-240VAC, 50/60Hz,<br>1.4A | 100-240VAC, 50/60Hz,<br>24VDC, 2.5A Max | Similar |
| Safety<br>classification | ClassI Type B | ClassI Type B | Same |
| Dimensions | 380(W)*430(L)*220(H)<br>mm | 210 (W)*210 (L)*<br>140(H) mm | Different |
| Weight | 11kg | ≤4KG NW | Different |
| Waterproof<br>level | IPX1 | IPX0 | Different |
| Footswitch<br>Waterproof<br>level | IPX8 | IPX8 | Same |
| 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 | Same |
| Non- sterile | Fiber is sterilized by EO. | Fiber is sterilized by<br>EO. | Same |
| Microprocess<br>or 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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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.
7. 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.
