(76 days)
No
The summary describes a phototherapy device that uses LEDs to emit UV light for treating skin conditions. There is no mention of AI or ML in the device description, intended use, performance studies, or any other section. The software documentation is for a basic documentation level, which is unlikely to involve complex AI/ML algorithms.
Yes
The device is intended to be used for the treatment of various skin conditions, such as psoriasis and vitiligo, which clearly indicates a therapeutic purpose.
No
The device is described as a "Phototherapy System" intended for treatment of various skin conditions using UV radiation, not for diagnosis. Its purpose is therapeutic.
No
The device description explicitly states 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." These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of various skin conditions (psoriasis, vitiligo, etc.) using UV phototherapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "therapeutic product" that uses UV light for "phototherapy." It is applied to intact skin for localized treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information for the diagnosis of a disease or condition. IVD devices are specifically designed for these purposes.
The device is clearly intended for therapeutic use by applying UV radiation to the skin to treat diagnosed conditions.
N/A
Intended Use / Indications 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.
Product codes
FTC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intact skin only, partial treatment excluding eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the direction of a physician, in hospital, clinics and households.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electromagnetic Compatibility and Electrical Safety Test:
The subject device passed safety testing according to AAMI/IEC 60601-1:2005/(R)2012 and A1:2012,C1:2019/(R)2012 and A2:2010/(R)2012; ANSI AAMI IEC 60601-1-2: 2014; IEC 60601-1-11 Edition 2.0 2015-01; IEC 60601-2-57 Edition 1.0 2011-01; IEC 60601-2-83 Edition 1.0 2019-05; and IEC 62471 First edition 2006-07.
Biocompatibility Test:
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." This included:
- Cytotoxicity per ISO 10993-5: 2009
- Sensitization per ISO 10993-10: 2021
- Irritation per ISO 10993-23: 2021
Key Results: The user-contacting materials were shown to be non-cytotoxic, non-irritating and non-sensitizing.
Software:
Software documentation 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", issued 06/14/2023, to support a device's Basic Documentation Level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
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.
1
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
2
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
3
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 |
5
4. Reference Device
| Items | Reference 1 | Reference 2 |
|---|---|---|
| 510(K) Number: | K170489 | K191571 |
| Manufacturer: | Clarify Medical, Inc. | Xuzhou Yongkang Electronic |
| Science 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 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.
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.
6
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 Phototherapy | ||
| System | UV Radiation Treatment | ||||
| System | / | ||||
| 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 and | |||
| households | Home / Physician's office | Hospitals, clinics and | |||
| households | Same | ||||
| Indications 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. | 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. | The Clarify Medical | ||||
| Phototherapy System is an | |||||
| Ultraviolet Light Emitting | |||||
| Medical Device. It is intended | |||||
| for use in localized | |||||
| phototheraputic treatment of | |||||
| dermatologic conditions such | |||||
| as psoriasis, vitiligo, atopic | |||||
| dermatitis (eczema), seborrheic | |||||
| dermatitis and lenkoderma on | |||||
| all skintypes (I-VI). | The UV Radiation Treatment | ||||
| System models YK-6000A, YK- | |||||
| 6000A-T, YK-6000B, and YK- | |||||
| 6000B-T, are intended for use | |||||
| under the direction of a | |||||
| physician, for the treatment of | |||||
| vitiligo, psoriasis, and eczema. | |||||
| The devices are intended for | |||||
| treatment of these conditions | |||||
| on 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) excimer | |||
| lamp | LED UV lamps | LED UV lamps | Same | ||
| UV spectral | UVB | UVB | UVB | UVA&UVB | Same |
| UV light | |||||
| wavelength | 308nm±2nm | 308nm±2nm | 300nm-320nm | UVA: 320nm~400nm | |
| UVB: 300nm~320nm | Same | ||||
| Max Power Output | UV-K&UV-X: 30 mW/cm² | ||||
| UV-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 |
| Maximum | |||||
| treatment dose | ≤ 5J/cm2 | 2J/cm2 | Not Publicly Available | Not Publicly Available | Comparable |
| Action area | Partial treatment excluding eyes | Partial treatment excluding | |||
| eyes | Not Publicly Available | Partial treatment excluding | |||
| eyes | Same | ||||
| Treatment area | 3cm2 ~ 3.41cm² | 16cm2 | 4.5cm2 | Max 15cm² | Comparable |
| Treatment time | UV-K&UV-X: 1~140s | ||||
| UV-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 device | ||
| and start button on host body | Hardware interface | Same | |||
| Power source | UV-K & UV-Y: Adapter | ||||
| UV-X & UV-Z: Adapter + lithium battery | Adapter | Rechargeable battery | AC outlet | Same | |
| Operating | |||||
| environment | 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/Storage | |||||
| environment | Ambient temperature: -20℃~50℃ | ||||
| Relative humidity: ≤ 93% | |||||
| Atmospheric pressure: | |||||
| 700hPa~1060hPa | Ambient temperature: | ||||
| -20℃~45℃ | |||||
| Relative humidity: 10-85%RH | |||||
| Atmospheric pressure: | |||||
| 500hPa~1060hPa | Not Publicly Available | Not Publicly Available | Comparable | ||
| Safety & | |||||
| Performance | IEC60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-11 | |||||
| IEC 62471 | |||||
| IEC 60601-2-57 | |||||
| IEC 60601-2-83 | IEC 60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-2-57 | |||||
| IEC 62471 | IEC60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-4 | |||||
| IEC 60601-2-57 | |||||
| IEC 62471 | IEC60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-2-57 | |||||
| IEC 62471 | Same | ||||
| Patient-Contact | |||||
| materia | ABS; PC | ABS; PC | ABS | ABS | Same |
7
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.
8
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.
-
- 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.
-
- 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.
-
- 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
-
- 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
-
- 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:
-
- 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
-
- 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.