(367 days)
Not Found
No
The description focuses on the hardware (excimer lamp, touch screen) and standard safety/performance testing, with no mention of AI/ML terms or functionalities like image processing, data analysis for treatment optimization, or learning algorithms.
Yes
The device is intended for the treatment of psoriasis and vitiligo, which are medical conditions, and therapeutic devices are defined as those used for treating or alleviating a disease or condition. The performance study references a standard specifically for "nonlaser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use," further supporting its therapeutic classification.
No
The device description and intended use clearly state that the 308nm Excimer System is for the "treatment" of psoriasis and vitiligo. There is no mention of diagnosis.
No
The device description explicitly states it is an "ultraviolet light system" with a "xenon-chloride excimer lamp" and mentions hardware components like a "control touch screen" and "colour-coded indicator light." It also lists performance studies related to electrical and light source equipment standards (IEC 60601 series), indicating a significant hardware component. While it mentions IEC 62304 for software, this is a standard for medical device software life-cycle processes and does not imply the device is software-only.
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 using light therapy on intact skin. IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a light system that generates UV light for therapeutic purposes. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any aspects typically associated with IVDs, such as sample collection, reagents, analytical methods, or diagnostic results.
This device is a therapeutic device that uses light energy to treat skin conditions.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
308nm Excimer System is an ultratraviolet light system 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 wavelenath of 308 nm. It displays the treatment parameters. Users can set the device and fluence on the control touch screen and determine the machine's state and function under the help of colour-coded indicator light.
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)
308nm Excimer System has been evaluated the safety and performance by lab bench testing as following:
- IEC 60601-1:2005+A1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance,
- IEC 60601-1-2:2007/(R)2012, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility
- IEC 60601-2-57 (First Edition): 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment -- Part 2: Particular requirements for the basic safety and essential performance of nonlaser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- IEC 62304: 2006 (First Edition), Medical device software, Software life- cycle processes.
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 & Human Services and the Food and Drug Administration (FDA). The Department of Health & 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. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 30, 2018
Chongqing Peninsula Medical Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou. 510000 Cn
Re: K172273
Trade/Device Name: 308nm Excimer System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: June 30, 2018 Received: July 5, 2018
Dear Cassie Lee:
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/cfpmr/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
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -53
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172273
Device Name 308nm Excimer System
Indications for Use (Describe)
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.
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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Chapter 5. 510(k) Summary
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Chongqing Peninsula Medical Technology Co., Ltd. Establishment Registration Number: Applying D-U-N-S Number: 545832254 Address: No.2-4, 2F Block I, Biological and Biochemical Park , 70-1&70-2# Ke Yuan 4th Road, Jiulongpo District, Chongqing, China Tel: +86-15012578550 Fax: +86-023-68611963 Contact Person: Zhang Sudi Email: zsd@peninsulalaser.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663. China Tel: +86-20-61099984 Email: regulatory@glomed-info.com
2. Subject Device Information
Trade Name: 308nm Excimer System Models: XECL-308C, XECL-308D Common Name: Powered Laser Surgical Instrument Classification name: Light, Ultraviolet, Dermatological Review Panel: Dermatology, Physical Medicine Product Code: FTC Regulation Class: II Regulation Number: 878.4630
3. Predicate Device Information
510(K) Number: K150752 Company Name: GME German Medical Engineering GmbH Address: Grimmstrasse 23, Bavaria, Germany 90491 Trade/Device Name: GME ExSys 308 Models: --Common Name: Ultraviolet Lamp for Dermatologic disorders
4
| Sponsor: | Chongqing Peninsula Medical Technology Co., Ltd. |
|---|---|
| Subject Device: | 308nm Excimer System, Models: XECL-308C, XECL-308D |
| Document Name: | FDA 510(k) Submission Report |
Requlation Number: 878.4630 Requlatory Class: II Product Code: FTC
4. Device Description
308nm Excimer System is an ultratraviolet light system 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 wavelenath of 308 nm. It displays the treatment parameters. Users can set the device and fluence on the control touch screen and determine the machine's state and function under the help of colour-coded indicator light.
The mechanism of 308nm Excimer System as shown below:
Image /page/4/Picture/5 description: The image shows a diagram of the effects of 308nm light on skin cells. The first diagram shows lesion T cells attacking melanin cells in the follicle, which makes melanin cells less and less. The second diagram shows that 308nm Excimer systems induced the lesion T cells and stimulate the melanin cells proliferation and differentiation in the follicle. The image also states that 308nm Excimer light can make T cell apoptosis and stimulate the melanin cells proliferation and differentiation.
5. Intended Use / Indications for Use
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.
6. Test Summary
308nm Excimer System has been evaluated the safety and performance by lab bench testing as following:
- � IEC 60601-1:2005+A1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance,
- � IEC 60601-1-2:2007/(R)2012, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility
- � IEC 60601-2-57 (First Edition): 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment -- Part 2: Particular requirements for the basic safety and essential performance of nonlaser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- � IEC 62304: 2006 (First Edition), Medical device software, Software life- cycle processes.
7. Comparison to predicate device and conclusion
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| Sponsor: | Chongqing Peninsula Medical Technology Co., Ltd. |
|---|---|
| Subject Device: | 308nm Excimer System, Models: XECL-308C, XECL-308D |
| Document Name: | FDA 510(k) Submission Report |
The technological characteristics, features, specifications, materials, mode of operation, and intended use of 308nm Excimer System is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Company | Chongqing Peninsula M | ||
| edical Technology Co., | |||
| Ltd. | GME German Medical | ||
| Engineering Gmbh | -- | ||
| Device Name and Model | 308nm Excimer System, | ||
| Models: XECL-308C, | |||
| XECL-308D | ExSys 308 System, | ||
| Models: -- | -- | ||
| Classification Name | Light, Ultraviolet, | ||
| Dermatological | Light, Ultraviolet, | ||
| Dermatological | SE | ||
| 510(k) Number | K172273 | K150752 | -- |
| Product code | FTC | FTC | SE |
| Intended Use & Indications | |||
| for Use | 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 GME 308nm | ||
| Excimer 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) ±3 | ||
| nm | 308 nm+/-4nm | SE | |
| Note 2 | |||
| Light Source | Xenon-Chlorine (XeCl) | ||
| excimer lamp produces | |||
| monochromatic UVB | |||
| light | XeCl excimer lamp | ||
| produces | |||
| monochromatic UVB | |||
| light | SE | ||
| Light Delivery | Light source in the | ||
| Applicator handpiece | Light source is in the | ||
| Applicator handpiece | SE | ||
| Cooling of light source | Air circulation cooling | Integrated air cooling | SE |
| Treatment Area | 16 cm² (4 x 4 cm) | 50x35 mm² | SE |
| Note 2 | |||
| Maximum Beam Power | 800 mW | 875 mW | SE |
| Note 2 | |||
| Maximum Beam Power | |||
| Density | 50 mW/cm2 | 50 mW/cm2 | SE |
| Beam Class | III | III | SE |
| Pulse Duration | 1s to 40 s | 1 sec - 40 sec | SE |
| Controls | Handswitch | Footswitch or | |
| handswitch | SE | ||
| Note 1 | |||
| Power Supply | Adapter Input: 100~240 | ||
| Vac, 0.8 A, 50/60 Hz | Adaptor Input: | ||
| 100~240 Vac, 50/60 | SE | ||
| Note 1 | |||
| Elements of Comparison | Subject Device | Predicate Device | Remark |
| Main unit input: 48 Vdc, | |||
| 2.94 A, 135 VA max | Hz, 0.1 A | ||
| Main Unit Input: 5 Vdc, | |||
| 1 A | |||
| 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. | Applicator 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 | Comply with IEC | ||
| 60601-1 and IEC | |||
| 60601-2-57 | SE | ||
| Weight |