(90 days)
No
The summary describes a simple phototherapy device with adjustable irradiation time and a light comb. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on electrical safety and biocompatibility, not algorithmic performance.
Yes
The device is described as being for "treatment," and IEC 60601-2-57: 2011, a standard it complies with, specifically refers to "therapeutic" use.
No
The device is described as a "therapeutic product" and is intended for the "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)" using ultraviolet radiation. It does not perform diagnostic functions. While one of the referenced standards (IEC 60601-2-57: 2011) mentions diagnostic use, the device's specific intended use and description point to therapy only.
No
The device description explicitly states it consists of hardware components: "LED lamp, irradiator, control circuit."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of skin conditions (psoriasis, vitiligo, atopic dermatitis) using UV light. IVDs are used for diagnosis of diseases or conditions by examining samples from the human body.
- Device Description: The description details a therapeutic device that delivers UV radiation to the skin. It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, and biocompatibility, which are relevant for a therapeutic device. There are no studies related to diagnostic accuracy or the analysis of biological samples.
Therefore, the Narrowband UV Phototherapy Light Lamp is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Narrowband UV Phototherapy Light Lamp is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.
Product codes
FTC
Device Description
The proposed device, Narrowband UV Phototherapy Light Lamp is a portable medical device that consists of LED lamp, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment excluding eyes. Irradiation time can be adjusted from 0~299s and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in two models: model HB-UPLL-01and model HB-UPLL-02.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Partial treatment excluding eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by or under the direction of a physician / hospitals, 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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 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 - Requirements and tests.
IEC 60601-1-11:2015, 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: 2011, 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 62471:2006, Photobiological safety of lamps and lamp systems
Biocompatibility Test
ISO 10993-5:2009,Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation
No clinical study is included in this submission.
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.
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March 27, 2023
Shenzhen Honpal Optoelectronic Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K223882
Trade/Device Name: Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: December 6, 2022 Received: December 27, 2022
Dear Boyle Wang:
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
1
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
510(k) Number (if known) K223882
Device Name
Narrowband UV Phototherapy Light Lamp(Model:HB-UPLL-01, HB-UPLL-02)
Indications for Use (Describe)
The Narrowband UV Phototherapy Light Lamp is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.
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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3
510(k) Summary
K223882
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | ||||
|---|---|---|---|---|---|
| Address: | Room 505,Shenghui Building A,Xixiang Street,Baonan District,Shenzhen City,Guangdong Province,China | ||||
| Tel: | +86-15986705009 | ||||
| Contact: | Wang Tianming |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, |
| 200120 China | |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: Mar.21,2023
2.0 Device Information
| Trade/Device name: | Narrowband UV Phototherapy Light Lamp |
|---|---|
| Common name: | Ultraviolet Lamp for Dermatologic Disorders |
| Classification name: | Light, Ultraviolet, Dermatological |
| Model(s): | HB-UPLL-01, HB-UPLL-02 |
| Production code: | FTC |
| Regulation number: | 21 CFR 878.4630 |
| Classification: | Class II |
| Panel: | General & Plastic Surgery |
3.0 Predicate Device Information
Predicate Device#
Xuzhou Kernel Medical Equipment Co., LTD. Manufacturer:
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UV Phototherapy Device: 510(k) number: K181805
Reference Device # Manufacturer: ALLUX MEDICAL Device: RESOLVE UVB PHOTOTHERAPY SYSTEM 510(k) number: K072035
4.0 Indication for Use Statement
The Narrowband UV Phototherapy Light Lamp is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.
5.0 Device Description
The proposed device, Narrowband UV Phototherapy Light Lamp is a portable medical device that consists of LED lamp, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment excluding eyes. Irradiation time can be adjusted from 0~299s and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in two models: model HB-UPLL-01and model HB-UPLL-02.
The device can be used in hospitals, clinics and households.
6.0 _Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 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 - Requirements and tests.
IEC 60601-1-11:2015, 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: 2011, Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source
5
equipment intended for therapeutic, diagnostic, monitoring and cosmetic/ aesthetic use.
IEC 62471:2006, Photobiological safety of lamps and lamp systems
Biocompatibility Test
ISO 10993-5:2009,Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation
7.0 _Clinical Test Conclusion
No clinical study is included in this submission.
8.0 Technological Characteristic Comparison Table
Table1-General Comparison
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| Item | Subject Device
K223882 | Predicate Device
K181805 | Reference Device
K072035 | Remark |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | FTC | FTC | FTC | Same |
| Regulation No. | 21 CFR 878.4630 | 21 CFR 878.4630 | 21 CFR 878.4630 | Same |
| Class | II | II | II | Same |
| Intended
Use/Indication for
Use | The Narrowband UV
Phototherapy Light Lamp is
intended for use, by or under the
direction of a physician for the
treatment of psoriasis, vitiligo,
and atopic dermatitis (eczema). It
is intended for use on all skin
types (I-VI).
It can be used in hospitals, clinics
and households. | The UV Phototherapy is
intended for use, by or under the
direction of a physician for the
treatment of psoriasis, vitiligo,
and atopic dermatitis (eczema).
It is intended for use on all skin
types (I-VI). It can be
used in hospitals, clinics and
households. | The ResolveTM UVB
Phototherapy System is an
ultraviolet light emitting
medical device for localized
phototherapeutic treatment of
dermatologic conditions such
as psoriasis, vitiligo, atopic
dermatitis (eczema), and
seborrheic dermatitis. The
ResolveTM UVB Phototherapy
System is intended to be used
with all Skin Types (I - VI). | Same |
| Prescriptive | Yes | Yes | Yes | Same |
| Mode of operation | Handheld | Handheld | Not Publicly Available | Same |
| Shell material | ABS | ABS | Not Publicly Available | Same |
| Treatment Area | Partial treatment excluding eyes | Partial treatment excluding eyes | Partial treatment excluding
eyes | Same |
| Treatment Time | 0299s | 0180s | Not Publicly Available | Different |
| Test Frequency | 35 times per week | 35 times per week | Not Publicly Available | Same |
| Treatment Area | HB-UPLL-01: 30 cm² | 60cm²/100cm²/104cm² | 12.8 x 9.0 cm | Different |
| | HB-UPLL-02: 7 cm² | | | |
| Irradiation Intensity | HB-UPLL-01: UVB: 2.0 MW/cm²
HB-UPLL-02: UVB: 1.2 MW/cm² | UVA: 150 MW/cm²20 MW/cm² | 1 mW/cm² | Similar |
UVB: 0.3
| Working distance | HB-UPLL-01:3cm;
HB-UPLL-02:2cm | 3 cm | Not Publicly Available | Same |
| UV spectral output | UVB | UVA or UVB | UVB | Same |
| Lamp configuration | 1 or 2 UV tube | 1 or 2
9W UV tube | Not Publicly Available | Same |
| Power Source | DC inlet | AC outlet or DC jack | AC outlet | Same |
| Wavelength range
(nm) | UVB: 280320 | UVA: 350400
UVB: 310~315 | 300-320nm | Similar |
| IPX - Rating / water
resistance | IP22 | IP22 | Not Publicly Available | Same |
| Application
Environment | Hospitals, Clinics and
Households. | Hospitals, Clinics and
Households. | Hospitals, Clinics and
Households. | Same |
| Electrical
Safety/Performance | Comply with IEC60601-1 and IEC
60601-2-57 | Comply with IEC60601-1 and
IEC 60601-2-57 | Comply with IEC60601-1 and
IEC 60601-2-57 | Same |
| Home Use | Comply with IEC 60601-1-11 | Comply with IEC 60601-1-11 | Comply with IEC 60601-1-11 | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Single Use | No | No | No | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO
10993-10:2021)
Irritation (ISO 10993-23:2021) | Under the conditions of the
study, Comply with the
requirements | Under the conditions of the
study, Comply with the
requirements | Same |
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8
Analysis:
The Irradiation Intensity of the proposed devices, but the value range of UVB is within that of the predicate device K181805 and between the value of the reference device K072035. So the we can think the slight differences will not affect the substantive equivalence.
The output specifications as "Treatment time" of the proposed device are a little different from the predicate devices, but they are considered substantially equivaled the performance tests in accordance with same standards: IEC 6001-1, IEC 60601-1-2 and IEC 60601-2-57,So there are no safety and effectiveness aspects concerned.
In conclusion, the technological characteristics, features, mode of the device substantially equivalent to the predicate devices quoted above. The subject device and predicate devices do not raise new issues of safety of effectiveness.
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The substantive equivalence to the predicate device.