308nm Excimer System is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelenath of 308 nm. It displays the treatment parameters. Users can set the device and fluence on the control touch screen and determine the machine's state and function under the help of colour-coded indicator light.

AI/ML Overview

The provided document is an FDA 510(k) premarket notification for a medical device (308nm Excimer System) and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics typically associated with AI/ML-based medical devices or diagnostic tools.

This document primarily focuses on establishing "substantial equivalence" of the 308nm Excimer System to a legally marketed predicate device (GME ExSys 308) for treating psoriasis and vitiligo. The "tests" mentioned are bench testing for electrical safety, electromagnetic compatibility, and general safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57) and software lifecycle processes (IEC 62304). These are regulatory compliance tests, not performance studies as would be conducted for a diagnostic device's accuracy or an AI algorithm's effectiveness in a clinical context.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance in the context of accuracy, sensitivity, specificity, or clinical utility as would be applicable to an AI device. The document does not describe such a study.

The questions you asked are relevant for AI/ML medical devices where performance benchmarks and clinical validation studies are crucial. This document, however, describes a light therapy device where the primary regulatory hurdle is demonstrating equivalence to an existing device, not proving a new clinical efficacy or diagnostic accuracy.

Summary

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July 30, 2018

Chongqing Peninsula Medical Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou. 510000 Cn

Re: K172273

Trade/Device Name: 308nm Excimer System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: June 30, 2018 Received: July 5, 2018

Dear Cassie Lee:

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/cfpmr/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -53

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172273

Device Name 308nm Excimer System

Indications for Use (Describe)

The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

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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Chapter 5. 510(k) Summary

510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Chongqing Peninsula Medical Technology Co., Ltd. Establishment Registration Number: Applying D-U-N-S Number: 545832254 Address: No.2-4, 2F Block I, Biological and Biochemical Park , 70-1&70-2# Ke Yuan 4th Road, Jiulongpo District, Chongqing, China Tel: +86-15012578550 Fax: +86-023-68611963 Contact Person: Zhang Sudi Email: zsd@peninsulalaser.com

Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663. China Tel: +86-20-61099984 Email: regulatory@glomed-info.com

2. Subject Device Information

Trade Name: 308nm Excimer System Models: XECL-308C, XECL-308D Common Name: Powered Laser Surgical Instrument Classification name: Light, Ultraviolet, Dermatological Review Panel: Dermatology, Physical Medicine Product Code: FTC Regulation Class: II Regulation Number: 878.4630

3. Predicate Device Information

510(K) Number: K150752 Company Name: GME German Medical Engineering GmbH Address: Grimmstrasse 23, Bavaria, Germany 90491 Trade/Device Name: GME ExSys 308 Models: --Common Name: Ultraviolet Lamp for Dermatologic disorders

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Sponsor:	Chongqing Peninsula Medical Technology Co., Ltd.
Subject Device:	308nm Excimer System, Models: XECL-308C, XECL-308D
Document Name:	FDA 510(k) Submission Report

Requlation Number: 878.4630 Requlatory Class: II Product Code: FTC

4. Device Description

The mechanism of 308nm Excimer System as shown below:

Image /page/4/Picture/5 description: The image shows a diagram of the effects of 308nm light on skin cells. The first diagram shows lesion T cells attacking melanin cells in the follicle, which makes melanin cells less and less. The second diagram shows that 308nm Excimer systems induced the lesion T cells and stimulate the melanin cells proliferation and differentiation in the follicle. The image also states that 308nm Excimer light can make T cell apoptosis and stimulate the melanin cells proliferation and differentiation.

5. Intended Use / Indications for Use

The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

6. Test Summary

308nm Excimer System has been evaluated the safety and performance by lab bench testing as following:

� IEC 60601-1:2005+A1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance,
� IEC 60601-1-2:2007/(R)2012, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility
� IEC 60601-2-57 (First Edition): 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment -- Part 2: Particular requirements for the basic safety and essential performance of nonlaser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
� IEC 62304: 2006 (First Edition), Medical device software, Software life- cycle processes.

7. Comparison to predicate device and conclusion

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Sponsor:	Chongqing Peninsula Medical Technology Co., Ltd.
Subject Device:	308nm Excimer System, Models: XECL-308C, XECL-308D
Document Name:	FDA 510(k) Submission Report

The technological characteristics, features, specifications, materials, mode of operation, and intended use of 308nm Excimer System is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements of Comparison	Subject Device	Predicate Device	Remark
Company	Chongqing Peninsula Medical Technology Co.,Ltd.	GME German MedicalEngineering Gmbh	--
Device Name and Model	308nm Excimer System,Models: XECL-308C,XECL-308D	ExSys 308 System,Models: --	--
Classification Name	Light, Ultraviolet,Dermatological	Light, Ultraviolet,Dermatological	SE
510(k) Number	K172273	K150752	--
Product code	FTC	FTC	SE
Intended Use & Indicationsfor Use	The 308nm ExcimerSystem is intended to beused for the treatment ofpsoriasis and vitiligo. Itis to be used on intactskin only.	The GME 308nmExcimer is intended tobe used for thetreatment of psoriasisand vitiligo. It is to beused on intact skin only	SE
Mode ofOperation	Continuous light source	Continuous lightsource	SE
Wavelength	308 nanometers (nm) ±3nm	308 nm+/-4nm	SENote 2
Light Source	Xenon-Chlorine (XeCl)excimer lamp producesmonochromatic UVBlight	XeCl excimer lampproducesmonochromatic UVBlight	SE
Light Delivery	Light source in theApplicator handpiece	Light source is in theApplicator handpiece	SE
Cooling of light source	Air circulation cooling	Integrated air cooling	SE
Treatment Area	16 cm² (4 x 4 cm)	50x35 mm²	SENote 2
Maximum Beam Power	800 mW	875 mW	SENote 2
Maximum Beam PowerDensity	50 mW/cm2	50 mW/cm2	SE
Beam Class	III	III	SE
Pulse Duration	1s to 40 s	1 sec - 40 sec	SE
Controls	Handswitch	Footswitch orhandswitch	SENote 1
Power Supply	Adapter Input: 100~240Vac, 0.8 A, 50/60 Hz	Adaptor Input:100~240 Vac, 50/60	SENote 1
Elements of Comparison	Subject Device	Predicate Device	Remark
	Main unit input: 48 Vdc,2.94 A, 135 VA max	Hz, 0.1 AMain Unit Input: 5 Vdc,1 A
Power CalibrationMethod	Internal, automatic	Internal, automatic	SE
MED DoseDetermination	Menu driven	Menu driven	SE
SterilizationAspects	Optical head reducermask is disinfectedbetween patients.	Applicator isdisinfectedbetween patients.	SE
Dosage Controls	Dosage (or energydensityJ/cm2), pulse duration	Dosage (or energydensityJ/cm2), pulse duration	SE
Display	Touch Screen ControlPanel	Touch Screen ControlPanel	SE
Patient Leakage Current	Complied with IEC60601-1 and IEC 60601-2-57	Comply with IEC60601-1 and IEC60601-2-57	SE
Weight	< 2.6 kg	12 kg	SENote 1
Dimensions(H x W x D)	26 cm x 24 cm x 27 cm(For lamp)5 cm x 9.5 cm x 18 cm(For Adapter)	25 cm x 30 cm x 30 cm	SENote 1
Operating Environment	Temperature: 15~35°C,Humidity: ≤ 80%RH,Atmospheric Pressure:86 ~ 106 kPa	Temperature: 5~~45°C,Humidity: 20~~65% RH	SENote 1
Storage Environment	Temperature: -20~45°C,Humidity: 10-85%RHAtmospheric Pressure:50 ~ 106 kPa	Temperature: 0~~45°C,Humidity: 10~~90% RH,Electrode Pad:10~20°C	SENote 1
Electrical Safety	Comply with IEC 60601-1 and IEC 60601-2-57	Comply with IEC60601-1 and IEC60601-2-57	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC60601-1-2	SE

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Comparison in Detail(s):

Note 1:

Although the "Power Supply", "Weight", "Dimension", "Operating Environment" and "Storage Environment" are a little different from the predicate devices, they all comply with IEC 60601-1 and IEC 60601-2-57 requirements. So the differences will not raise any safety or effectiveness issue.

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Sponsor:	Chongqing Peninsula Medical Technology Co., Ltd.
Subject Device:	308nm Excimer System, Models: XECL-308C, XECL-308D
Document Name:	FDA 510(k) Submission Report

Note 2:

Although some output specifications "Wavelength", "Treatment area", "Output Intensity", and "Maximum Beam Power" are a little different from the predicate devices, they all comply with IEC 6060 1-1, IEC 60601-1-2, IEC 60601-2-57 requirement. So the differences of function specification will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device "308nm Excimer System" is Substantial Equivalent to the predicate devices.

8. Date of the summary prepared: June 30, 2018

Regulation Number and Section

§ 878.4630 Ultraviolet lamp for dermatologic disorders.

(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.