The Medical Diode Laser use a wavelength 1940nm 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: M2) 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 400um and 600um in diameter and with SMA905 connectors.

AI/ML Overview

This document is about the 510(k) premarket notification for a Medical Diode Laser (M2) by Wuhan Pioon Technology Co., Ltd. The document does not describe a study involving acceptance criteria and device performance in the way typically associated with AI/algorithm-based medical devices.

Instead, this submission is for a physical medical device (a laser surgical instrument) and focuses on demonstrating substantial equivalence to a predicate device (Fotona SkyPulse Laser Platform) based on technical characteristics and compliance with recognized performance standards.

Here's an analysis based on the provided text, addressing the requested points where applicable, and noting when information is not present:

A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria and device performance in terms of specific clinical or algorithmic metrics (like sensitivity, specificity, or AUC) as would be typical for an AI/CADe device.
Instead, the "performance data" for this laser device refers to compliance with established electrical safety, electromagnetic compatibility (EMC), and software standards. The acceptance criterion is implicitly successful demonstration of compliance with these standards.

Table: Performance Data and Compliance

Performance Area	Acceptance Criteria (Standards)	Reported Device Performance (Compliance)
Electrical safety	IEC 60601-1:2005+AMD1:2012+AMD2:2020IEC 60601-2-22:2019	Complies
Electromagnetic compatibility (EMC)	IEC 60601-1-2:2014+A1:2020	Complies
Laser product safety	IEC 60825-1:2014	Complies
Software Verification and Validation	FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate level of concern)	Documentation provided and testing conducted; software considered verified and validated

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not applicable and not provided as this is not an AI/CADe device that uses a test set of patient data for performance evaluation. The "tests" here refer to engineering and quality assurance tests on the physical device and its software.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided as this is not an AI/CADe device requiring expert ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable and not provided. The device is a surgical laser, not an AI diagnostic or assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable and not provided. The device is a physical laser for surgical use, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not applicable and not provided in the context of clinical "ground truth" for patient data analysis. The ground truth, in the context of this device, refers to the established standards and specifications that the device must meet (e.g., electrical safety tolerances, EMC emissions limits, software functional requirements).
The sample size for the training set
- This information is not applicable and not provided as this is not an AI/machine learning device.
How the ground truth for the training set was established
- This information is not applicable and not provided.

Summary of the Study (as described in the document):

The "study" refers to the engineering and regulatory testing performed to demonstrate the safety and effectiveness of the Medical Diode Laser (M2) by showing its compliance with recognized national and international standards.

Type of Study: This is a premarket notification (510(k)) submission for a physical medical device. The "studies" involve compliance testing against recognized standards for electrical safety, electromagnetic compatibility, and laser product safety, as well as software verification and validation.
Performance Data Provided:
- Electrical safety and EMC: The device complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 standards.
- Software Verification and Validation: Conducted according to FDA guidance for "moderate" level of concern software.
Conclusion: Based on these technical characteristics and performance data, the Medical Diode Laser was found to have a safety and effectiveness profile "same as the predicate device."
Animal or clinical studies: The document explicitly states "None," indicating that no animal or clinical studies were performed or required for this 510(k) submission to demonstrate substantial equivalence.

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). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 31, 2023

Wuhan Pioon Technology Co.,Ltd. Feng Zhang Official Primary Correspondent and Management Representative 7th Floor, A21 of Sino Pharm Building, Biolake Innovation Park, No.666 Gaoxin Avenue Wuhan, Hubei 430075 China

Re: K230274

Trade/Device Name: Medical Diode Laser (M2) 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: January 30, 2023 Received: February 1, 2023

Dear Feng Zhang:

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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Indications for Use

Submission Number (if known)

K230274

Device Name

Medical Diode Laser (M2)

Indications for Use (Describe)

Medical Diode Laser is intended to incision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.

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

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K230274

I. Submitter

Device Submitter: Wuhan Pioon Technology Co.,Ltd.
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 andManagement Representative
	Phone: +86 18062448535
	E-mail: zhangfeng@pioon.com

Date Prepared: December 8, 2022

Type of 510(k):	Traditional
Trade name:	N/A,
Device name:	Medical Diode Laser, Model: M2
Common Name:	Powered Laser Surgical Instrument
Regulation:	878.4810 - Laser surgical instrument for use in generaland plastic surgery and in dermatology
Medical Specialty:	General & Plastic Surgery
Regulatory Class:	II
Product Code:	GEX

III. Predicate Device

Fotona SkyPulse Laser Platform (K193656), 1940nm Diode Laser. This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. Device Description

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V. Indications for Use

Medical Diode Laser is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.

Comparison of Technological Characteristics with the Predicate Device VI.

The predicated device is Fotona SkyPulse Laser Platform (K193656), a 1940nm Diode Laser with same intended use as the subject device.

Item	Subject device(this submission)	Predicated device(K193656)
Product Code	GEX	GEX
Regulation NO.	21 CFR 878.4810	21 CFR 878.4810
Class	II	II
Indications forUse	Medical Diode Laser isintended to incision, excision,ablation, vaporization,hemostasis and/or coagulationof soft tissue.	Medical Diode Laser is intendedto incision, excision, ablation,vaporization, hemostasis and/orcoagulation of soft tissue.
Use of device	RX only	RX only
Energy source	Solid state diode	Solid state diode
Configuration	Main UnitFoot Control	Main UnitFoot Control
LaserWavelength	1940nm	1940nm
LaserClassification	Class IV	Class IV
Power range	Up to 7.5W	Up to 7.5W
Pulse width	CW or 10 ms – 10 s	CW or 10 ms – 10 s
Repetition rate	CW or up to 100 Hz	CW or up to 100 Hz
Delivery system	Fiber delivery	Fiber delivery
User interface	Touch screen control	Touch screen control

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Wuhan Pioon Technology Co., Ltd PN/FDA-M2-25

Safety feature	Complied with:	Complied with:
	IEC 60601-1:2005+AMD1:2012+AMD2:2020(IEC60601-1:2020)	IEC 60601-1:2005+A1:2012
	IEC 60601-1-2:2014+A1:2020	IEC 60601-1-2:2014
	IEC 60601-2-22:2019	IEC 60601-2-22:2007+A1:2012
	IEC 60825-1:2014	IEC 60825-1:2014

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Medical Diode Laser and optical fibers. The Medical Diode Laser complies with the IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-2-22:2019 and IEC 60825-1:2014 standards for safety and the IEC 60601-1-2:2014+A1:2020 standard for EMC.

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.

Summary

Based on the clinical performance, technological characteristics and performance data as documented in the submission, the Medical Diode Laser was found to have a safety and effectiveness profile that is same as the predicate device.

VIII. Conclusions

Based on its technical characteristics, performance test data, and its indications for use as above summary, we conclude that the subject device is as safe and effective as the predicate device.

Animal or clinical studies: None

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.