The 308nm UV Phototherapy System is intended to be used for the treatment of psorrasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is used on intact skin only.

Device Description

The 308nm UV Phototherapy System is available in four models, UV-K , UV-Y and UV-Z. It is a portable medical device, which consists of LED light board, heat dissipation module, control circuit, drive circuit, battery (applicable to UV-X, UV-Z), and power adapter. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders, which can be used in hospital, clinics and households.

The device is mainly composed of a host and a power adapter. The LED light board of the device host contains light emitting diodes (LEDs), which create narrowband UVB light centered at a wavelength 308nm(±2nm) for the purpose of phototherapy. They are intended to be use in localized phototherapeutic treatment of dermatologic conditions(excluding eyes), such as psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is for the partial treatment and is intended to be used on intact skin only.

The materials of the parts of the 308nm UV Phototherapy System that come into contact with the human body are mainly: PC, ABS.

AI/ML Overview

This document describes the 510(k) summary for the Boston Aesthetics INC 308nm UV Phototherapy System (UV-K; UV-X; UV-Y; UV-Z). Below is a summary of the acceptance criteria and the study that proves the device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (K172273 - 308nm Excimer System) and reference devices (K170489 - Clarify Phototherapy System, K191571 - UV Radiation Treatment System). The "acceptance criteria" are not explicitly listed with numerical thresholds in the provided document, but rather are implied by the demonstration that the subject device's characteristics are similar or comparable and that non-clinical performance testing meets established standards.

| Feature / Criteria (Implied) | Acceptance Criteria (Implied by Predicate/Reference) | Reported Device Performance (Subject Device K244022) | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Treatment of specific dermatologic conditions on intact skin, under prescription. (Predicate: psoriasis, vitiligo; Reference: adds atopic dermatitis, seborrheic dermatitis, leukoderma) | Intended for treatment of psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. Used on intact skin only. (Prescription use in hospitals, clinics, and households). | Similar & Comparable |
| Light Source | Xenon-Chlorine (XeCI) excimer lamp or LED UV lamps (Predicate: XeCI excimer lamp; Reference 1 & 2: LED UV lamps) | LED UV lamps | Same |
| UV Spectral Output | UVB (Predicate: UVB; Reference 1: UVB; Reference 2: UVA&UVB) | UVB | Same |
| UV Light Wavelength | 308nm±2nm (Predicate and Reference 2 UVB: 308nm±2nm or 300nm-320nm; Reference 1: 300nm-320nm) | 308nm±2nm | Same |
| Max Power Output | Comparable to predicate/reference devices (Predicate: 50mW/cm²; Reference 1: 3-15mW/cm²; Reference 2: 10mW/cm²) | UV-K&UV-X: 30 mW/cm²; UV-Y&UV-Z: 50 mW/cm² | Comparable |
| Maximum Treatment Dose | ≤ 5J/cm² (Predicate: 2J/cm²) | ≤ 5J/cm² | Comparable |
| Action Area | Partial treatment excluding eyes (Predicate and Reference 2: Partial treatment excluding eyes) | Partial treatment excluding eyes | Same |
| Treatment Area | Comparable to predicate/reference devices (Predicate: 16cm²; Reference 1: 4.5cm²; Reference 2: Max 15cm²) | 3cm² ~ 3.41cm² | Comparable |
| Treatment Time | Comparable to predicate/reference devices (Predicate: 1~~40s; Reference 2: 5~~20 min) | UV-K&UV-X: 1~~140s; UV-Y&UV-Z: 1~~100s | Comparable |
| User-Contacting Materials| Safe and biocompatible materials (Predicate: ABS; PC; Reference 1: ABS; Reference 2: ABS) | ABS; PC (demonstrated non-cytotoxic, non-irritating, non-sensitizing via ISO 10993-5, -10, -23) | Same |
| Safety and Performance | Compliance with recognized electrical safety, EMC, and photobiological safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471 generally common across predicates/references) | Compliance with: AAMI/IEC 60601-1:2005/(R)2012+A1+A2, ANSI AAMI IEC 60601-1-2: 2014, IEC 60601-1-11:2015, IEC 60601-2-57:2011, IEC 60601-2-83:2019, IEC 62471:2006. Biocompatibility testing per ISO 10993-5, -10, -23. Software documentation compliant with FDA guidance. | Same |

Study Proving Device Meets Acceptance Criteria:

The provided document describes a non-clinical performance testing approach to demonstrate substantial equivalence, rather than a clinical study with patient outcomes.

Study Type: Non-clinical (bench testing, biocompatibility, and software documentation).
Objective: To demonstrate that the 308nm UV Phototherapy System is as safe and effective as the predicate device (K172273) and reference devices by meeting recognized performance standards and having comparable technological characteristics.

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

This is not a clinical study involving a "test set" of patients or data in the typical sense for performance metrics like sensitivity/specificity. Instead, it relies on:

Bench Test Samples: The device units themselves (UV-K, UV-X, UV-Y, UV-Z models) are the "samples" for electrical safety, EMC, and photobiological safety testing. The number of units tested is not specified but is assumed to be sufficient for compliance with the relevant standards.
Biocompatibility Samples: Samples of the user-contacting materials (PC, ABS) were tested. The number of samples is not specified but is assumed to follow the requirements of ISO 10993 standards.
Data Provenance: Not applicable in the context of clinical data. The data comes from internal testing and validation against international and national standards.

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

This information is not applicable. The assessment is based on objective testing against predetermined engineering and safety standards, not on expert interpretations of clinical images or outcomes.

4. Adjudication Method for the Test Set

Not applicable, as this is objective non-clinical testing against standards.

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

Not applicable. This device is a phototherapy system, not an AI-assisted diagnostic tool where human reader performance would be a primary metric.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device for therapeutic use, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for demonstrating safety and effectiveness in this context is:

Compliance with Recognized Standards: Meeting the requirements of international and national standards for medical electrical equipment (IEC 60601 series), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series).
Comparison to Predicate Device: Demonstrating that the subject device's technological characteristics and intended use are similar or comparable to a legally marketed predicate device cleared by the FDA, without raising new questions of safety or effectiveness.

8. Sample Size for the Training Set

Not applicable. This is a hardware therapeutic device, not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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Boston Aesthetics INC Cao Hongmei General Manager 1521 Concord Pike Suite 201 Wilmington, Delaware 19803

Re: K244022

Trade/Device Name: 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: December 26, 2024 Received: December 27, 2024

Dear Cao Hongmei:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Digitally signed by YAN FU -S
YAN FU-S Date: 2025.03.13 19:17:31
-04'00'

for Tanisha Hithe 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) K244022

Device Name

308mm UV Phototherapy System (UV-K): 308mm UV Phototherapy System (UV-X): 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

Indications for Use (Describe)

The 308nm UV Phototherapy System is intended to be used for the treatment of psorrasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is used on intact skin only.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K244022 - 510(k) Summary

This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.

1. Administrative Information

Submission Date

December 26, 2024

Submission Correspondent

Name: Boston Aesthetics INC Address: 1521 Concord Pike Suite 201 Wilmington DE 19803 Tel: +001 949-792-8168 E-mail: bsnaesthetics@gmail.com Contact: Ms. Hongmei Cao

2. Device Information

Type of 510(k) Submission:	Traditional
Device Name:	308nm UV Phototherapy System
Model:	UV-K; UV-X; UV-Y; UV-Z
Device Classification:	Light, Ultraviolet, Dermatological
Regulation Description:	Ultraviolet lamp for dermatologic disorders
Regulation Medical Specialty:	General & Plastic Surgery
Regulation Number:	878.4630
Product Code:	FTC
Device Class:	2

3. Predicate Device

510(K) Number:	K172273
Device name:	308nm Excimer System
Device model:	XECL-308C
Manufacturer:	Chongqing Peninsula Medical Technology Co., Ltd.
Classification Name:	Ultraviolet lamp for dermatologic disorders
Regulation Medical Specialty:	General&Plastic Surgery
Product code:	FTC
Regulation number:	878.4630

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4. Reference Device

Items	Reference 1	Reference 2
510(K) Number:	K170489	K191571
Manufacturer:	Clarify Medical, Inc.	Xuzhou Yongkang ElectronicScience Technology Co., Ltd
Device name:	Clarify Phototherapy System	UV Radiation Treatment System
Model:	N/A	YK-6000B
Classification Name:	Ultraviolet lamp for dermatologic disorders
Regulation Medical Specialty:	General&Plastic Surgery
Product code:	FTC
Regulation number:	878.4630

5. Device Description

The materials of the parts of the 308nm UV Phototherapy System that come into contact with the human body are mainly: PC, ABS.

5. Indication for Use

The 308nm UV Phototherapy System is intended to be used for the treatment of psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is used on intact skin only.

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6. Comparison with predicate device

A comparison of the intended use and technological characteristics of the subject device is provided in the table below:

Items	Subject Device (K######)	Predicate Device (K172273)	Reference Device (K170489)	Reference Device (K191571)	Comparison
Device name	308nm UV Phototherapy System	308nm Excimer System	Clarify Medical PhototherapySystem	UV Radiation TreatmentSystem	/
Device model	UV-K, UV-X, UV-Y, UV-Z	XECL-308E	N/A	YK-6000A	/
Device picture	Image: 308nm UV Phototherapy System	Image: 308nm Excimer System	Image: Clarify Medical Phototherapy System	Image: UV Radiation Treatment System	/
Type of Use	Prescription Use	Prescription Use	Prescription Use	Prescription Use	Same
Use environment	Hospitals, clinics and households	Hospitals, clinics andhouseholds	Home / Physician's office	Hospitals, clinics andhouseholds	Same
Indications for use	The 308nm UV Phototherapy System isintended to be used for the treatment ofpsoriasis, vitiligo, seborrheic dermatitis,atopic dermatitis, and leukoderma. It isused on intact skin only.	The 308nm Excimer System isintended to be used for thetreatment of psoriasis andvitiligo. It is to be used on intactskin only.	The Clarify MedicalPhototherapy System is anUltraviolet Light EmittingMedical Device. It is intendedfor use in localizedphototheraputic treatment ofdermatologic conditions suchas psoriasis, vitiligo, atopicdermatitis (eczema), seborrheicdermatitis and lenkoderma onall skintypes (I-VI).	The UV Radiation TreatmentSystem models YK-6000A, YK-6000A-T, YK-6000B, and YK-6000B-T, are intended for useunder the direction of aphysician, for the treatment ofvitiligo, psoriasis, and eczema.The devices are intended fortreatment of these conditionson Fitzpatrick Skin Types (I-VI).	Similar &Comparable
Mode of operation	Handheld	Handheld	Handheld	Handheld	Same
Re-usable	Yes	Yes	Yes	Yes	Same
Light source	LED UV lamps	Xenon-Chlorine (XeCI) excimerlamp	LED UV lamps	LED UV lamps	Same
UV spectral	UVB	UVB	UVB	UVA&UVB	Same
UV lightwavelength	308nm±2nm	308nm±2nm	300nm-320nm	UVA: 320nm~~400nmUVB: 300nm~~320nm	Same
Max Power Output	UV-K&UV-X: 30 mW/cm²UV-Y&UV-Z: 50 mW/cm²	50mW/cm²	3-15mW/cm²	10mW/cm²	Comparable
Items	Subject Device (K######)	Predicate Device (K172273)	Reference Device (K170489)	Reference Device (K191571)	Comparison
Maximumtreatment dose	≤ 5J/cm2	2J/cm2	Not Publicly Available	Not Publicly Available	Comparable
Action area	Partial treatment excluding eyes	Partial treatment excludingeyes	Not Publicly Available	Partial treatment excludingeyes	Same
Treatment area	3cm2 ~ 3.41cm²	16cm2	4.5cm2	Max 15cm²	Comparable
Treatment time	UV-K&UV-X: 1~~140sUV-Y&UV-Z: 1~~100s	1~40s	Not Publicly Available	5~20 min	Comparable
Display Type	OLED	Not Publicly Available	Not Publicly Available	LED	Same
User Interface	Hardware interface	Hardware interface	Touch screen on mobile deviceand start button on host body	Hardware interface	Same
Power source	UV-K & UV-Y: AdapterUV-X & UV-Z: Adapter + lithium battery	Adapter	Rechargeable battery	AC outlet	Same
Operatingenvironment	Ambient temperature: 5℃~~35℃Relative humidity: ≤ 80%Atmospheric pressure:780hPa~~1060hPa	Ambient temperature:15℃~~35℃Relative humidity: ≤ 80%Atmospheric pressure:860hPa~~1060hPa	Not Publicly Available	Not Publicly Available	Comparable
Transport/Storageenvironment	Ambient temperature: -20℃~~50℃Relative humidity: ≤ 93%Atmospheric pressure:700hPa~~1060hPa	Ambient temperature:-20℃~~45℃Relative humidity: 10-85%RHAtmospheric pressure:500hPa~~1060hPa	Not Publicly Available	Not Publicly Available	Comparable
Safety &Performance	IEC60601-1IEC 60601-1-2IEC 60601-1-11IEC 62471IEC 60601-2-57IEC 60601-2-83	IEC 60601-1IEC 60601-1-2IEC 60601-2-57IEC 62471	IEC60601-1IEC 60601-1-2IEC 60601-1-4IEC 60601-2-57IEC 62471	IEC60601-1IEC 60601-1-2IEC 60601-2-57IEC 62471	Same
Patient-Contactmateria	ABS; PC	ABS; PC	ABS	ABS	Same

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The subject device and the predicate device have intended use. Although the subject device have several different technological characteristics as noted in the differences do not raise different questions of safety and effectiveness. Therefore, we consider that the subject device is as safe and effective as the predicate device.

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7. Summary of Non-Clinical performance Testing

7.1. Electromagnetic Compatibility and Electrical Safety Test

The subject device has passed safety testing in according to following standards.

AAMI/IEC 60601-1:2005/(R)2012 and A1:2012,C1:2019/(R)2012 and A2:2010/(R)2012 Medical 1) electrical equipment - Part 1: General requirements for basic safety and essential performance.
1. ANSI AAMI IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances-Requirements and tests.
1. IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
1. IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
1. IEC 60601-2-83 Edition 1.0 2019-05 Medical electrical equipment -Part 2-83: Particular requirementsfor the basic safety and essential performance of home lighttherapy equipment
1. IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems

7.2. Biocompatibility Test

Biocompatibility testing was conducted in accordance with the 2020 FDA guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Device Part 1: Evaluation and Testing." The testing includes:

1. Cytotoxicity per ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity.
Sensitization per ISO 10993-10: 2021 Biological evaluation of medical devices Part 10: Tests for 2) skin sensitization
1. Irritation per ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation

The user- contacting materials were shown to be non-cytotoxic, non-irritating and non-sensitizing.

7.3. Software

Software documentation of the subject device was provided in accordance with the FDA guidance Document- "Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff", which was issued in 06/14/2023 to support a device's Basic Documentation Level.

8. Conclusion

The subject device and the predicate device have the same intended use and any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness. The results of the testing described above demonstrate that the subject device is as safe and effective as the predicate device (K172273) and supports a determination of substantial equivalence.

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.