The 308nm Excimer System (model: XECL-308E) is an Ultraviolet Light Emitting Medical Device. It is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. It is to be used on intact skin only.

Device Description

The 308nm Excimer System (model: XECL-308E)is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types (I-VI). The system including a main body, power line, handpiece holder, XeCl lamp, handpiece, and output light window adapter. The handpiece includes a contains light emitting diodes (LEDs), which create an array of narrowband UVB light centered at a wavelength mainly between 308±2 nm. The device should be operated by a professional doctor in the hospital for the treatment.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) summary for the "308nm Excimer System" (model: XECL-308E), which is an Ultraviolet Light Emitting Medical Device. It describes the device's indications for use, its comparison to predicate devices, and lists various electrical safety and electromagnetic compatibility standards it complies with (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62304 for software).

However, none of the details you requested regarding acceptance criteria, device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information for an AI/ML device are present. The device described here is a physical medical device (an excimer lamp), not an AI/ML software device.

Summary

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May 13, 2020

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Chongqing Peninsula Medical Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biologcial Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou Guangzhou, 510000 Cn

Re: K192642

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: March 8, 2020 Received: March 17, 2020

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/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.

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

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801 and Part 809); 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,

Colin Kejing Chen, Ph.D. 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

510(k) Number (if known) K192642

Device Name

308nm Excimer System (Model: XECL-308E)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over The Counter Use (21 CFR 807)
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| X 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 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: Chongging Peninsula Medical Technology Co., Ltd. Address: No.2-4, 2F Block |, 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: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: requlatory@glomed-info.com

2. Subject Device Information

Trade Name: 308nm Excimer System Models: XECL-308E Common Name: Light, Ultraviolet, Dermatological Classification name: Ultraviolet lamp for dermatologic disorders Review Panel: Dermatology, Physical Medicine Product Code: FTC Regulation Class: II Regulation Number: 878.4630

3. Predicate Device Information 1

510(K) Number: K173436 Company Name: Luma Therapeutics Trade/Device Name: Luma Light System Common Name: Light, Ultraviolet, Dermatological Regulation Number: 878.4630 Regulatory Class: II Product Code: FTC Intended Use: / Indications for Use: The LUMA™ Light System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types (I-VI),

Predicate Device Information 2

510(K) Number: K172273 Company Name: Chongqing Peninsula Medical Technology Co., Ltd.

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Trade/Device Name: 308nm Excimer System Common Name: Light, Ultraviolet, Dermatological Regulation Number: 878.4630 Regulatory Class: II Product Code: FTC 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.

Predicate Device Information 3

510(K) Number: K191086 Company Name: Clarteis Trade/Device Name: Exciplex Common Name: Light, Ultraviolet, Dermatological Regulation Number: 878.4630 Regulatory Class: II Product Code: FTC Intended Use: / Indications for Use: The Exciplex is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. The reusable polycarbonate/ABS reduction tips and reusable silicone masks are for use on intact skin only.

4. Device Description

5. Intended Use / Indications for Use

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 60601-1-2:2014, 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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Elements ofComparison	Subject Device	PredicateDevice 1	PredicateDevice 2	PredicateDevice 3(Referencedevice)	Remark
Company	Chongqing Peninsula Medical Technology Co.,Ltd.	LumaTherapeutics	Chongqing Peninsula Medical Technology Co.,Ltd.	Clarteis	--
Device Nameand Model	308nm ExcimerSystem, Model:XECL-308E	Luma LightSystem,	308nm ExcimerSystem	Exciplex	--
ClassificationName	Ultraviolet lampfor dermatologicdisorders	Ultraviolet lampfor dermatologicdisorders	Ultraviolet lampfor dermatologicdisorders	Ultraviolet lampfor dermatologicdisorders	SE
510(k)Number	Applying	K173436	K172273	K191086	--
Classification	Class II	Class II	Class II	Class II	SE
Product code	FTC	FTC	FTC	FTC	SE
Intended Use& Indicationsfor Use	The 308nmExcimer System(model: XECL-308E) is anUltraviolet LightEmittingMedical Device.It is intended tobe used for thetreatment ofpsoriasis,vitiligo, atopicdermatitis, andleukoderma. Itis to be used onintact skin only.	The LUMA™Light System isan UltravioletLight EmittingMedical Device.It is intended foruse in localizedphototherapeutictreatment ofdermatologicconditions suchas psoriasis,vitiligo, atopicdermatitis(eczema),seborrheicdermatitis, andleukoderma onall skin types (I-VI).	The 308nmExcimer Systemis intended to beused for thetreatment ofpsoriasis andvitiligo. It is to beused on intactskinonly.	The Exciplex is intended to be used for the treatment of psoriasis,vitiligo, atopic dermatitis, and leukoderma.The reusable polycarbonate/ABSreduction tips and reusable silicone masks are foruse on intact skinonly.	SE
Wavelength	$308±2$ nm	$300 – 320$ nm	$308±3$ nm	$308$ nm	SE
Light Source	Xenon-Chlorine(XeCl) excimerlamp producesmonochromaticUVB light	LED lamps	Xenon-Chlorine(XeCl) excimerlamp producesmonochromaticUVB light	Excimer devicethat emits UVBlight	SE
Light Delivery	Light source inthe Applicatorhandpiece	Light source inthe Hand piece(light module)	Light source inthe Applicatorhandpiece	/	SE
DeliveryMethod	Treatmentwindow	Treatmentwindow	/	Output window	SE
Cooling of	Cooling fan	/	Air circulation	/	--
Elements ofComparison	Subject Device	PredicateDevice 1	PredicateDevice 2	PredicateDevice 3(Referencedevice)	Remark
light source			cooling
TreatmentArea	$6cm^2~28.8 cm^2$	$20.2 cm^2$	$16 cm^2$ (4 x 4cm)	$25 cm^2$ (5 x 5cm)	SENote1
Max PowerOutput	$50 mW/cm^2$	4.2 - 7.2$mW/cm^2$	$50 mW/cm^2$	$100 mW/cm^2$	SENote1
Treatmenttime	1-140s	Timer to controltreatmentduration storedin the softwarebased onprescription	1-40s	/	SENote1
Controls	Hand-switch	Hand piece(light module)with wirelessconnection tomobile phonePhysician setsfrequency andduration oftreatments byprogrammingapp in phone	Hand-switch	/	SE
UseEnvironment	Physician Office	Home /Physician Office		/	SE
User Interface	Touch ScreenControl	Touch screen onthe MobileDevice	Touch ScreenControl Panel	/	SENote2
Dimensions(H x W x D)	548.0mm253.6mm181.4mm	/	For lamp: 26 cmx 24 cm x 27 cmFor Adapter: 5cm x 9.5 cm x18 cm
OperatingEnvironment	Temperature:5℃~30℃Humidity:≤80%RHAtmosphericPressure: 700 ~1060 hPa	/	Temperature:15~35°C,Humidity: ≤80%RH,AtmosphericPressure:86 ~ 106 kPa
StorageEnvironment	Temperature:0℃~40℃Humidity:≤85%RHAtmosphericPressure: 700 ~1060 hPa	/	Temperature: -20~45°C,Humidity: 10-85%RHAtmosphericPressure:50 ~ 106 kPa
Elements ofComparison	Subject Device	PredicateDevice 1	PredicateDevice 2	PredicateDevice 3(Referencedevice)	Remark
ElectricalSafety	Comply withIEC 60601-1and IEC 60601-2-57	Complied withIEC 60601-1and IEC 60601-2-57	Comply with IEC60601-1 andIEC 60601-2-57	Complied withIEC 60601-1 andIEC 60601-2-57	SE
EMC	Comply withIEC 60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	SE

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Comparison in Detail(s):

Note 1:

Although some output specifications as "Max Power Output", "Treatment area", and "Treatment time" of the subject device are a little different from the predicate devices, but they are considered as a same level, and they all comply with the standards: IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-57, and range between the predicate device K173436 and predicate device K191086. So the we can think that the slight differences in specification will not raise any safety or effectiveness issue.

Note 2:

Althouqh the "User Interface" of subject device is a little different from the predicate devices, but both predicate device and subject device have passed the evaluation complied with IEC 60601-1, these parameters are not impact on the safety and effectiveness, so we considered they are equivalent as the differences will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device "308nm Excimer System (model: XECL-308E)" is in the same design principle and utilizing identical Light Source (UV lamps) as the predicate devices. The "Indications for use" and technological characteristics (as Light Source, Wavelength, Delivery Method, Treatment area, Treatment time and Use Environment) are the same or similar to those of the predicate devices. So the subject device is Substantial Equivalent to the predicate devices K172237 and K191086.

8. Date of the summary prepared: May 12, 2020

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.