(133 days)
Not Found
No
The summary describes a traditional phototherapy device and its safety and performance testing, with no mention of AI or ML.
Yes
The device is intended for the treatment of medical conditions (psoriasis and vitiligo) and uses phototherapy, which is a therapeutic intervention.
No
The device is intended for the treatment of psoriasis and vitiligo using phototherapy, not for diagnosing these conditions.
No
The device description and performance studies clearly indicate this is a hardware device that emits UV light for phototherapy, not a software-only device. The testing includes electrical safety, photobiological safety, biocompatibility, and equipment performance testing, all related to hardware components. While software verification and validation are mentioned, this is for the control software of the hardware device.
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 psoriasis and vitiligo" on "intact skin." This describes a therapeutic device that interacts directly with the patient's body for treatment purposes.
- Device Description: The description talks about "UVB therapy" and "artificial light source" for treating "various skin diseases." This further reinforces its role as a therapeutic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a phototherapy device used for direct treatment of skin conditions.
N/A
Intended Use / Indications for Use
308nm Excimer Phototherapy Device is intended to be used for 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
Ultraviolet phototherapy originated in the 1920s. Due to the development of science and technology, the technology of artificial light source has developed rapidly. UVB therapy, as a representative, has become one of the effective methods to treat various skin diseases in developed countries such as Europe and America.
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
Not Found
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 Performed:
Electrical Safety and Electromagnetic Compatibility Testing - 308nm Excimer Phototherapy Device CN-308E, KN-4003B4, KN-5000C KN-5000D, KN-5000D, KN-5000H, KN-5000K equipment has been tested and meets the following standard requirements of medical equipment:
• IEC 60601-1:2020 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance.
· IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests.
· IEC 60601-2-83:2019 Medical electrical equipment - Part 2-83: Particular reguirements for the basic safety and essential performance of home light therapy equipment.
· IEC 60601-1-11:2020 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.
Photobiological Safety Testing - The 308nm Excimer Phototherapy Device CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K have been tested and comply with IEC 62471:2006, Photobiological safety of lamps and lamp systems, 1st edition. This IEC standard incorporates the principles of the following ANSI IESNA recommended practices:
· RP 27.1:2005 Recommended practice for photobiological safety for lamps and lamp systems -General requirements.
· RP 27.2:2000 Recommended practice for photobiological safety for lamps and lamp systems -Measurement techniques.
· RP-27.3:2007 Recommended practice for photobiological safety for lamps and lamp systems -Risk group classification and labeling.
Biocompatibility test - The 308nm Excimer Phototherapy Device CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K have been tested and comply with ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021.
Software Verification and Validation - Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Equipment performance testing and verification- The 308nm Excimer Phototherapy Device CN-308E. KN-4003B3. KN-4003 B4. KN-5000C. KN-5000H. and KN-5000K were subjected to equipment performance testing (testing items include: Appearance; Spectral peak wavelength; UV irradiation intensity; UV irradiation dose; Effective irradiation zone, Timing and functions, Safety test: Continuous leakage current, Continuous leakage current, Continuous leakage current; Dielectric strength; Dielectric strength; Packaging inspection); At the same time, a device temperature test was conducted to verify that the skin surface temperature remained between 32-41℃ throughout the specified treatment time of 0-120 seconds. The device has passed all the tests mentioned above, and based on these test results, the manufacturer believes that the 308nm Excimer Phototherapy Devices CN-308E, KN-4003B3, KN-4003B4, KN-5000C, KN-5000D, KN-5000H, and KN-5000K are essentially equivalent to the device without causing new safety and effectiveness issues.
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 6, 2025
Xuzhou Kernel Medical Equipment Co., Ltd. Che Gang Prrc Kernel Mansion, Economic Development District Xuzhou, Jiangsu 221004 China
Re: K242977
Trade/Device Name: 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D. KN-5000H. KN-5000K) Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: September 26, 2024 Received: September 26, 2024
Dear Che Gang:
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 (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/cdrb/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 OS 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 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 mediation-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 TANISHA TANISHA L. HITHE -S L. HITHE -○ Date: 2025.02.06
22:17:17 -05'00'
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) K242977
Device Name
308nm Excimer Phototherapy Device (CN-308E, KN-4003B4. KN-5000C KN-5000D, KN-5000H, KN-5000K)
Indications for Use (Describe) 308nm Excimer Phototherapy Device is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K242977 - 510(k) Summary
Date of Summary Preparation: January 15 2025
1. Submitter's Identifications
Submitter's Name: Xuzhou Kernel Medical Equipment Co., Ltd. Address: Kernel Mansion, Economic Development District, Xuzhou City, Jiangsu Province, China Contact Person: Che Gang Contact Title: PRRC Contact E-mail Address: chg(@)kernelmed.com Telephone: +86-516-87732208
2. Correspondent's Identifications
Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: Jiang13620586569@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549
3. Name of the Device
Device Classification Name: Light, Ultraviolet, Dermatological Trade Name: 308nm Excimer Phototherapy Device Model: CN-308E, KN-4003B3, KN-4003B4, KN-5000C,KN-5000D, KN-5000H, KN-5000K Classification Panel: General & Plastic Surgery Product Code: FTC Device Classification: Class II Regulation Number: 21 CFR 878.4630
4. The Predicate Devices
Predicate Devices K200971 308nm Excimer System Xuzhou Kernel Medical Equipment Co., Ltd.
5. Device Description
5.1 Device introduction:
Ultraviolet phototherapy originated in the 1920s. Due to the development of science and technology, the technology of artificial light source has developed rapidly. UVB therapy, as a representative, has become one of the effective methods to treat various skin diseases in developed
5
countries such as Europe and America.
6. Intended Use of Device
308nm Excimer Phototherapy Device is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
6
7. Summary of Substantial Equivalence
Table 1 Comparison to Predicate Device for 308nm Excimer Phototherapy Device
| Proposed Device | Predicate device | Comparison | ||
|---|---|---|---|---|
| 510k Number | K200971 | ------ | ||
| Product Code | FTC | FTC | Same | |
| Proprietary Name | 308nm Excimer Phototherapy Device | 308nm Excimer System | ------ | |
| Model | CN-308E, KN-4003B3, KN-4003B4, KN-5000C,KN-5000D, KN-5000H, KN-5000K | KN-5000C KN-5000D | ------ | |
| Manufacturer | Xuzhou Kernel Medical Equipment Co., Ltd. | Xuzhou Kernel Medical Equipment Co., | ||
| Ltd. | ------ | |||
| Indications for Use | 308nm Excimer Phototherapy Device 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. | Same | |||
| Prescription | ||||
| Required | Yes | Yes | Same | |
| Mode of Operation | Non-continuous operation | Non-continuous operation | Same | |
| Wavelength | 308 nm ±2nm | 308 nm ±2nm | Same | |
| Irradiation mode | Handheld irradiation | Handheld irradiation | Same | |
| Cooling of light | ||||
| source | Air cooling | Air cooling | Same | |
| Treatment Area | CN-308E:30cm2±10%; | |||
| KN-4003B3,KN-4003B4: | ||||
| 8cm2±10%; | ||||
| KN-5000C,KN-5000D: 20cm2±10%, | 20cm2±10% | Similar | ||
| The treatment area of the proposed | ||||
| device is similar to the predicates | ||||
| K200971. The proposed device has | ||||
| KN-5000H, KN-5000K: | ||||
| 12 cm²±10% | passed safety testing. This difference | |||
| will not improve the safety and | ||||
| effectiveness of the proposed | ||||
| equipment. | ||||
| Max. UV Irradiation | ||||
| Intensity | 10-70 mW/cm² | 50 mW/cm² | Similar | |
| The Max. UV Irradiation Intensity of | ||||
| the proposed device is similar to the | ||||
| predicate device K200971, so this | ||||
| definition does not affect the safety | ||||
| and effectiveness. | ||||
| Treatment Time | 0~120s | 0~120s | Same | |
| Maximum dose | 5000mJ/cm² | 5 J/cm² (5000mJ/cm²) | Same | |
| Power supply | AC 100-240V 50/60Hz | |||
| Input Power: | ||||
| KN-5000C: 160VA | ||||
| KN-5000D: 200VA | ||||
| CN-308E:120VA | ||||
| KN-5000H/KN-4003B3:40VA | ||||
| KN-5000K:70VA | ||||
| KN-4003B4: 50VA | AC100-240V, 50/60Hz | |||
| Input Power: | ||||
| KN-5000C: 160VA | ||||
| KN-5000D: 200VA | Similar | |||
| The “ Power supply ” is a little | ||||
| different from the predicate devices, | ||||
| but they all comply with IEC | ||||
| 60601-1, IEC 60601-1-2, IEC | ||||
| 60601-2-83 requirements. So | ||||
| the differences will not raise any | ||||
| safety or effectiveness issue. | ||||
| MED Dose | ||||
| Determinati on | Manual MED test | |||
| (KN-5000H is not applicable) | Manual MED test | Same | ||
| Display | Touch LCD screen | 8 inches touch LCD screen | Same | |
| Security Type | Classification by type of anti-electric shock: | |||
| Class II; | ||||
| Classification according to the degree of | ||||
| anti-electric shock: Type BF | Classification by type of anti-electric shock: | |||
| Class I; | ||||
| Classification according to the degree of | ||||
| anti-electric shock: Type B | Similar | |||
| The anti-electric shock type of | ||||
| household medical devices is BF. | ||||
| This product comply with IEC | ||||
| Patient Leakage | ||||
| Current | Complied with IEC 60601-1 and IEC | |||
| 60601-1-11, IEC 60601-2-83 | Complied with IEC 60601-1 and IEC | |||
| 60601-2-57 | 60601-1 requirements. The security | |||
| type does not affect the safety and | ||||
| effectiveness. | ||||
| Similar | ||||
| The Patient Leakage Current of the | ||||
| proposed device is similar to the | ||||
| predicates K200971. | ||||
| The proposed device has passed | ||||
| safety testing. This difference will | ||||
| not improve the safety and | ||||
| effectiveness of the proposed | ||||
| equipment. | ||||
| Operating | ||||
| Environment | Temperature: 5~35℃ | |||
| Relative humidity: ≤85% | ||||
| Atmospheric pressure:: | ||||
| 700hPa~1060hPa | Temperature: 5~35℃ | |||
| Relative humidity: ≤85% | ||||
| Atmospheric pressure:: | ||||
| 700hPa~1060hPa | Same | |||
| Environmental for | ||||
| transportation and | ||||
| storage | Ambient temperature:-40 ~ 55 °C | |||
| Relative humidity: ≤90% | ||||
| Atmospheric pressure:500 ~ 1060hpa | Ambient temperature:-40 ~ 55 °C | |||
| Relative humidity: ≤90% | ||||
| Atmospheric pressure:500 ~ 1060hpa | Same | |||
| Electrical Safety/ | ||||
| Performance | Comply with IEC60601-1 and | |||
| 60601-1-11, IEC 60601-2-83 | Comply with IEC60601-1 and IEC | |||
| 60601-2-57 | Similar | |||
| The Electrical Safety/ Performance of | ||||
| the proposed device is similar to the | ||||
| predicates K200971. The proposed | ||||
| device has passed safety testing. This | ||||
| difference will not improve the safety | ||||
| and effectiveness of the proposed | ||||
| equipment. | ||||
| Sterile | N/A | N/A | Same | |
| Single Use | No | No | Same | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | |
| Biocompatibility | Cytotoxicity (ISO10993-5:2009) | Cytotoxicity (ISO10993-5:2009) | Same | |
| Biocompatibility | Irritation (ISO 10993-23:2021) | Irritation (ISO 10993-10:2010) | Same | |
| Sensitization (ISO10993-10:2021) | Sensitization (ISO10993-10:2010) | Same | ||
| Label and Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | Same | |
| Discussion for | The proposed device 308nm Excimer Phototherapy Device has the same purpose as the predicate device: Product Code, Indications for | |||
| Substantially | Use, Prescription Required, Mode of Operation, Wavelength, Irradiation mode, Cooling of light source, Treatment Time, Maximum | |||
| Equivalent (SE) | dose, MED Dose Determination, Display, Operating Environment, Environmental for transportation and storage, Sterile, Single Use, | |||
| EMC , Biocompatibility and Label and Labeling. These items can be controlled within the scope of application. These small | ||||
| differences between the proposed devices and predicate devices do not cause new safety and effectiveness problems. According to the | ||||
| non-clinical test results, the proposed device is as safe, effective and has good performance as the predicate device. | ||||
| So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. |
7
8
9
8. Substantial Equivalence discussion:
The indication for use of the 308m Excimer Phototherapy Device CN-308E, KN-4003B4, KN-5000C KN-5000H, KN-5000H, KN-5000K are the same as that for the predicate devices. Most technications of the 308mn Excimer Phototherapy Device CN-308B, KN-4003B4, KN-5000C KN-5000H, KN-5000H, KN-5000K are either the same or substantially equivalent as compared to the predicate devices. There are no technological differences that raise new or different questions of safety or effectiveness.
10
9. Non-Clinical Tests Performed:
Electrical Safety and Electromagnetic Compatibility Testing - 308nm Excimer Phototherapy Device CN-308E, KN-4003B4, KN-5000C KN-5000D, KN-5000D, KN-5000H, KN-5000K equipment has been tested and meets the following standard requirements of medical equipment:
• IEC 60601-1:2020 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance.
· IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests.
· IEC 60601-2-83:2019 Medical electrical equipment - Part 2-83: Particular reguirements for the basic safety and essential performance of home light therapy equipment.
· IEC 60601-1-11:2020 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.
Photobiological Safety Testing - The 308nm Excimer Phototherapy Device CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K have been tested and comply with IEC 62471:2006, Photobiological safety of lamps and lamp systems, 1st edition. This IEC standard incorporates the principles of the following ANSI IESNA recommended practices:
· RP 27.1:2005 Recommended practice for photobiological safety for lamps and lamp systems -General requirements.
· RP 27.2:2000 Recommended practice for photobiological safety for lamps and lamp systems -Measurement techniques.
· RP-27.3:2007 Recommended practice for photobiological safety for lamps and lamp systems -Risk group classification and labeling.
Biocompatibility test - The 308nm Excimer Phototherapy Device CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K have been tested and comply with ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021.
Software Verification and Validation - Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Equipment performance testing and verification- The 308nm Excimer Phototherapy Device CN-308E. KN-4003B3. KN-4003 B4. KN-5000C. KN-5000H. and KN-5000K were subjected to equipment performance testing (testing items include: Appearance; Spectral peak wavelength; UV irradiation intensity; UV irradiation dose; Effective irradiation zone, Timing and functions, Safety test: Continuous leakage current, Continuous leakage current, Continuous leakage current; Dielectric strength; Dielectric strength; Packaging inspection); At the same time, a device temperature test was conducted to verify that the skin surface temperature remained between 32-41℃ throughout the specified treatment time of 0-120 seconds. The device has passed
11
all the tests mentioned above, and based on these test results, the manufacturer believes that the 308nm Excimer Phototherapy Devices CN-308E, KN-4003B3, KN-4003B4, KN-5000C, KN-5000D, KN-5000H, and KN-5000K are essentially equivalent to the device without causing new safety and effectiveness issues.
10. Conclusion:
Based on comparing to predicate device, the proposed device of 308nm Excimer py Device CN-308E, KN-4003B3, KN-4003B4, KN-5000D, KN-5000D, KN-5000H, KN-5000K are determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and effectiveness.
--- End of this section ---