(82 days)
Not Found
No
The device description focuses on the hardware components and the light emission technology. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The control touch screen is described for setting parameters and determining the machine's state, which is typical for non-AI/ML medical devices.
Yes
The device is described as a "Skin Therapy System" intended for the "treatment of psoriasis and vitiligo," indicating its use for therapeutic purposes.
No
The device is described as a "Skin Therapy System" intended for "treatment of psoriasis and vitiligo," explicitly stating its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is an "ultraviolet light emitting medical device" and describes physical hardware components like a main body, handpiece, footswitch, and power cord. While software validation is mentioned, the core function and components are hardware-based.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of psoriasis and vitiligo using UV light therapy. IVDs are used to diagnose diseases or conditions by examining samples from the human body (like blood, urine, tissue).
- Device Description: The device is described as an "ultraviolet light emitting medical device" that applies light to intact skin. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information.
Therefore, the 308nm Excimer UV-light Skin Therapy System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 308nm Excimer UV-light Skin Therapy System is intended to the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
The 308nm Excimer UV-light Skin Therapy System is ultraviolet light emitting medical device.
The model GP908B is a desktop device, consisting of a main body, handpiece, footswitch and power cord.
The model GP908D is a handheld device, consisting of a main body, power cord and adapter.
308nm Excimer UV-light Skin Therapy System is designed to be used in dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelength of 308 nm. Users can set the device parameter and determine the machine's state and function on the control touch screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intact skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dermatological practice
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)
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaws could directly result in minor injury to the patient or operator.
None of the tests demonstrated any design characteristics that violate the requirements of the Reviewer Guidance or show any safety hazards. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2020
Shenzhen GSD Tech Co., Ltd. Zoe Yao Quality Management Department Building A, JUNSD Hi-Tech Park, West of Bao'An RD. Watch & Clock Base, Guangming District Shenzhen, Guangdong 518106 China
Re: K202827
Trade/Device Name: 308nm Excimer UV-light Skin Therapy System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: October 19, 2020 Received: October 19, 2020
Dear Zoe Yao:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 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 (OS) 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.
Purva Pandya 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) K202827
Device Name 308nm Excimer UV-light Skin Therapy System
Indications for Use (Describe)
The 308nm Excimer UV-light Skin Therapy System is intended to the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21 CFR Section 807.92.
1. Submitter information
Shenzhen GSD Tech Co., Ltd Add .: Building A, JUNSD Hi-Tech Park, West of Bao'An RD. Watch & Clock Base, Guangming District, Shenzhen, China 518106 Establishment Registration Number: 3006580954
Contact Person: Huifang Yao Position: Regulatory Engineer Phone: +86 15018526594 E-mail: zoe.yao190322@qq.com.com
Date Prepared: Dec. 8, 2020
2. Device information
Trade name: 308nm Excimer UV-light Skin Therapy System Model number: GP908B, GP908D Regulation number: 21CFR 878.4630 Regulation name: Ultraviolet Lamp For Dermatologic Disorders Common name: Light, Ultraviolet, Dermatological Regulatory class: II Panel: General & Plastic Surgery Product code: FTC
3. Predicate device information
510(k) Number: K172273 Device Name: 308nm Excimer System Manufacturer: Chongqing Peninsula Medical Technology Co., Ltd.
4. Device description
The 308nm Excimer UV-light Skin Therapy System is ultraviolet light emitting medical device.
The model GP908B is a desktop device, consisting of a main body, handpiece, footswitch and power cord.
The model GP908D is a handheld device, consisting of a main body, power cord and adapter.
308nm Excimer UV-light Skin Therapy System is designed to be used in dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate
4
specific ultraviolet light at wavelength of 308 nm. Users can set the device parameter and determine the machine's state and function on the control touch screen.
5. Indications for Use
The 308nm Excimer UV-light Skin Therapy System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
6. Technological characteristics and substantial equivalence:
| Description | Subject device | Predicate device | Remark |
|---|---|---|---|
| Company | SHENZHEN GSD TECH CO.,LTD | Chongqing Peninsula Medical Technology Co., Ltd. | / |
| Device name and model | 308nm Excimer UV-light Skin Therapy System | ||
| Models: GP908B, GP908D | 308nm Excimer System, | ||
| Models: XECL-308C, XECL-308D | / | ||
| 510 (k) number | / | K172273 | / |
| Classification name | Ultraviolet Lamp For Dermatologic Disorders | Ultraviolet Lamp For Dermatologic Disorders | SE |
| Product code | FTC | FTC | SE |
| Regulation number | 21 CFR 878.4630 | 21 CFR 878.4630 | SE |
| Class | II | II | SE |
| Indications for use/ Intended use | The 308nm Excimer UV-light System is intended to be used for the treatment of psoriasis and vitiligo. It is to be 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. | SE |
| Mode of operation | Continuous light source | Continuous light source | SE |
| Wavelength | 308 nanometers (nm) ±2 nm | 308 nanometers (nm) ±3 nm | SE |
| Light source | Xenon-Chlorine (XeCl) excimer lamp produces monochromatic UVB light | Xenon-Chlorine (XeCl) excimer lamp produces monochromatic UVB light | SE |
| Light delivery | Light source in the Applicator handpiece | Light source in the Applicator handpiece | SE |
| Cooling of light source | Air circulation cooling | Air circulation cooling | SE |
| Treatment area | GP908B: | ||
| 22.62cm²(3.9cm*5.8cm) | 16 cm 2(4 x 4 cm) | SE | |
| Note 1 | |||
| GP908D: 16cm²(4×4cm) | |||
| Maximum Beam Power | GP908B: 1131mW | ||
| GP908D: 800mW | 800 mW | SE | |
| Maximum Beam Power | |||
| Density | 50 mW/cm² | 50 mW/cm² | SE |
| Beam class | III | III | SE |
| Pulse Duration | GP908B: 1s to 40s | ||
| GP908D: 1s to 40s | 1s to 40 s | SE | |
| Controls | GP908B: handswitch and | ||
| footswitch | |||
| GP908D: handswitch | Handswitch | SE | |
| Note 1 | |||
| Electrical Requirements | Adapter Input: 100~240Vac, | ||
| 0.8 A, 50/60 Hz | Adapter Input: 100~240Vac, 0.8 A, | ||
| 50/60 Hz | SE | ||
| Power Calibration Method | Internal, automatic | Internal, automatic | SE |
| MED Dose Determination | Menu driven | Menu driven | SE |
| Sterilization Aspects | Optical head reducer mask | ||
| is disinfected between | |||
| patients. | Optical head reducer mask is | ||
| disinfected between patients. | SE | ||
| Dosage Controls | Dosage (or energy density | ||
| J/cm²), pulse duration | Dosage (or energy density J/cm²), | ||
| pulse duration | SE | ||
| Display | Touch Screen Control Panel | Touch Screen Control Panel | SE |
| Patient Leakage Current | Complied with IEC 60601-1 | ||
| and IEC 60601-2-57 | Complied with IEC 60601-1 and | ||
| IEC 60601-2-57 | SE | ||
| Dimensions | |||
| (HWD) | GP908B: | ||
| 49.5cm×43cm×35cm | |||
| GP908D: | |||
| 36.5cm31.8cm40cm | 26cm24cm27cm (for lamp) | ||
| 5cm9.5cm18cm (for adapter) | SE | ||
| Note 2 | |||
| Operation Environment | Temperature: 5°C~+30°C | ||
| Humidity: ≤80%RH | |||
| Atmospheric pressure: | |||
| 86~106kPa | Temperature: 15~35℃ | ||
| Humidity: ≤80%RH | |||
| Atmospheric pressure: 50~106kPa | SE | ||
| Note 2 | |||
| Storage Environment | Temperature: -20°C~+55°C | ||
| Humidity: ≤93% | |||
| Atmospheric pressure: | |||
| 50~106kPa | Temperature: -20~45°C | ||
| Humidity: 10-85%RH | SE | ||
| Note 2 | |||
| Electrical Safety | Comply with IEC 60601-1 | ||
| and IEC 60601-2-57 | Comply with IEC 60601-1 and IEC | ||
| 60601-2-57 | SE | ||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
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Note 1: Although some output specifications (treatment area, controls) are a little different from the predicate devices, they all comply with the requirements of
6
IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-57.
Note 2: The "Dimensions", "Operating Environment" and "Storage Environment" are a little different from the predicate device, but they all comply with IEC 60601-1 and IEC 60601-2-57 requirements.
The differences will not raise any safety or effectiveness issues.
7. Nonclinical tests submitted
· Safety test
IEC 60601-1:2005/A1:2012
Medical electrical equipment Part1: General requirements for basic safety and essential performance
● EMC test
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
● Reliability test
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
● Biocompatibility test
ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
● Software Validation & Verification Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaws could directly result in minor injury to the patient or operator.
None of the tests demonstrated any design characteristics that violate the requirements of the Reviewer Guidance or show any safety hazards. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests.
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8. Conclusion
The subject devices have the same intended use and same technological characteristics as the predicate device. Moreover the differences between the subject and predicate don't raise new questions of safety or effectiveness. Thus, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.