(232 days)
No
The summary describes a light-emitting medical device for dermatological treatment and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "Medical Device" intended for "phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma." The specific mention of "therapeutic" use within the IEC standard it adheres to (IEC 60601-2-57) further confirms its therapeutic nature.
No
The device description and intended use clearly state that it is a treatment device, specifically for dermatologic conditions using UV light. There is no mention of it being used for diagnosis.
No
The device description explicitly lists hardware components such as a main body, power line, handpiece holder, XeCl lamp, and handpiece containing LEDs. The performance studies also include testing against hardware safety standards (IEC 60601 series).
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 dermatological conditions (psoriasis, vitiligo, etc.) by applying ultraviolet light to intact skin.
- Device Description: The device is described as an "Ultraviolet Light Emitting Medical Device" that uses a XeCl lamp and LEDs to deliver light for therapeutic purposes.
- Mechanism of Action: The device directly interacts with the patient's skin through light emission for therapeutic effect.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state, or to monitor therapeutic measures. This device does not perform any such analysis of specimens. It is a therapeutic device.
N/A
Intended Use / Indications for Use
The 308nm Excimer System (model: XECL-308E) is an Ultraviolet Light Emitting Medical Device. It is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. It is to be used on intact skin only.
Product codes
FTC
Device Description
The 308nm Excimer System (model: XECL-308E)is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types (I-VI). The system including a main body, power line, handpiece holder, XeCl lamp, handpiece, and output light window adapter. The handpiece includes a contains light emitting diodes (LEDs), which create an array of narrowband UVB light centered at a wavelength mainly between 308±2 nm. The device should be operated by a professional doctor in the hospital for the treatment.
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
professional doctor in the hospital
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 60601-1-2:2014, 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)
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
May 13, 2020
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 and the words "U.S. FOOD & DRUG ADMINISTRATION".
Chongqing Peninsula Medical Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biologcial Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou Guangzhou, 510000 Cn
Re: K192642
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: March 8, 2020 Received: March 17, 2020
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/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 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
1
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 (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,
Colin Kejing Chen, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K192642
Device Name
308nm Excimer System (Model: XECL-308E)
Indications for Use (Describe)
The 308nm Excimer System (model: XECL-308E) is an Ultraviolet Light Emitting Medical Device. It is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. 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 807) |
|---|---|
| ---------------------------------------------- | ----------------------------------- |
| X 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."
3
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: Chongging Peninsula Medical Technology Co., Ltd. Address: No.2-4, 2F Block |, 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: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: requlatory@glomed-info.com
2. Subject Device Information
Trade Name: 308nm Excimer System Models: XECL-308E Common Name: Light, Ultraviolet, Dermatological Classification name: Ultraviolet lamp for dermatologic disorders Review Panel: Dermatology, Physical Medicine Product Code: FTC Regulation Class: II Regulation Number: 878.4630
3. Predicate Device Information 1
510(K) Number: K173436 Company Name: Luma Therapeutics Trade/Device Name: Luma Light System Common Name: Light, Ultraviolet, Dermatological Regulation Number: 878.4630 Regulatory Class: II Product Code: FTC Intended Use: / Indications for Use: The LUMA™ Light System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types (I-VI),
Predicate Device Information 2
510(K) Number: K172273 Company Name: Chongqing Peninsula Medical Technology Co., Ltd.
4
Trade/Device Name: 308nm Excimer System Common Name: Light, Ultraviolet, Dermatological Regulation Number: 878.4630 Regulatory Class: II Product Code: FTC 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.
Predicate Device Information 3
510(K) Number: K191086 Company Name: Clarteis Trade/Device Name: Exciplex Common Name: Light, Ultraviolet, Dermatological Regulation Number: 878.4630 Regulatory Class: II Product Code: FTC Intended Use: / Indications for Use: The Exciplex is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. The reusable polycarbonate/ABS reduction tips and reusable silicone masks are for use on intact skin only.
4. Device Description
The 308nm Excimer System (model: XECL-308E)is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types (I-VI). The system including a main body, power line, handpiece holder, XeCl lamp, handpiece, and output light window adapter. The handpiece includes a contains light emitting diodes (LEDs), which create an array of narrowband UVB light centered at a wavelength mainly between 308±2 nm. The device should be operated by a professional doctor in the hospital for the treatment.
5. Intended Use / Indications for Use
The 308nm Excimer System (model: XECL-308E) is an Ultraviolet Light Emitting Medical Device. It is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. 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 60601-1-2:2014, 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
5
| Elements of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3
(Reference
device) | Remark |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Company | Chongqing Peni
nsula Medical T
echnology Co.,
Ltd. | Luma
Therapeutics | Chongqing Peni
nsula Medical T
echnology Co.,
Ltd. | Clarteis | -- |
| Device Name
and Model | 308nm Excimer
System, Model:
XECL-308E | Luma Light
System, | 308nm Excimer
System | Exciplex | -- |
| Classification
Name | Ultraviolet lamp
for dermatologic
disorders | Ultraviolet lamp
for dermatologic
disorders | Ultraviolet lamp
for dermatologic
disorders | Ultraviolet lamp
for dermatologic
disorders | SE |
| 510(k)
Number | Applying | K173436 | K172273 | K191086 | -- |
| Classification | Class II | Class II | Class II | Class II | SE |
| Product code | FTC | FTC | FTC | FTC | SE |
| Intended Use
& Indications
for Use | The 308nm
Excimer System
(model: XECL-
308E) is an
Ultraviolet Light
Emitting
Medical Device.
It is intended to
be used for the
treatment of
psoriasis,
vitiligo, atopic
dermatitis, and
leukoderma. It
is to be used on
intact skin only. | The LUMA™
Light System is
an Ultraviolet
Light Emitting
Medical Device.
It is intended for
use in localized
phototherapeutic
treatment of
dermatologic
conditions such
as psoriasis,
vitiligo, atopic
dermatitis
(eczema),
seborrheic
dermatitis, and
leukoderma on
all skin types (I-
VI). | 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 Exciplex is i
ntended to be us
ed for the treatm
ent of psoriasis,
vitiligo, atopic der
matitis, and leuk
oderma.
The reusable pol
ycarbonate/ABS
reduction tips an
d reusable silicon
e masks are for
use on intact skin
only. | SE |
| Wavelength | $308±2$ nm | $300 – 320$ nm | $308±3$ nm | $308$ nm | SE |
| Light Source | Xenon-Chlorine
(XeCl) excimer
lamp produces
monochromatic
UVB light | LED lamps | Xenon-Chlorine
(XeCl) excimer
lamp produces
monochromatic
UVB light | Excimer device
that emits UVB
light | SE |
| Light Delivery | Light source in
the Applicator
handpiece | Light source in
the Hand piece
(light module) | Light source in
the Applicator
handpiece | / | SE |
| Delivery
Method | Treatment
window | Treatment
window | / | Output window | SE |
| Cooling of | Cooling fan | / | Air circulation | / | -- |
| Elements of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3
(Reference
device) | Remark |
| light source | | | cooling | | |
| Treatment
Area | $6cm^2~28.8 cm^2$ | $20.2 cm^2$ | $16 cm^2$ (4 x 4
cm) | $25 cm^2$ (5 x 5
cm) | SE
Note1 |
| Max Power
Output | $50 mW/cm^2$ | 4.2 - 7.2
$mW/cm^2$ | $50 mW/cm^2$ | $100 mW/cm^2$ | SE
Note1 |
| Treatment
time | 1-140s | Timer to control
treatment
duration stored
in the software
based on
prescription | 1-40s | / | SE
Note1 |
| Controls | Hand-switch | Hand piece
(light module)
with wireless
connection to
mobile phone
Physician sets
frequency and
duration of
treatments by
programming
app in phone | Hand-switch | / | SE |
| Use
Environment | Physician Office | Home /
Physician Office | | / | SE |
| User Interface | Touch Screen
Control | Touch screen on
the Mobile
Device | Touch Screen
Control Panel | / | SE
Note2 |
| Dimensions
(H x W x D) | 548.0mm253.6
mm181.4mm | / | For lamp: 26 cm
x 24 cm x 27 cm
For Adapter: 5
cm x 9.5 cm x
18 cm | | |
| Operating
Environment | Temperature:
5℃30℃35°C,
Humidity:
≤80%RH
Atmospheric
Pressure: 700 ~
1060 hPa | / | Temperature:
15
Humidity: ≤
80%RH,
Atmospheric
Pressure:
86 ~ 106 kPa | | |
| Storage
Environment | Temperature:
0℃40℃45°C,
Humidity:
≤85%RH
Atmospheric
Pressure: 700 ~
1060 hPa | / | Temperature: -
20
Humidity: 10-
85%RH
Atmospheric
Pressure:
50 ~ 106 kPa | | |
| Elements of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3
(Reference
device) | Remark |
| Electrical
Safety | Comply with
IEC 60601-1
and IEC 60601-
2-57 | Complied with
IEC 60601-1
and IEC 60601-
2-57 | Comply with IEC
60601-1 and
IEC 60601-2-57 | Complied with
IEC 60601-1 and
IEC 60601-2-57 | SE |
| EMC | Comply with
IEC 60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | SE |
6
7
Comparison in Detail(s):
Note 1:
Although some output specifications as "Max Power Output", "Treatment area", and "Treatment time" of the subject device are a little different from the predicate devices, but they are considered as a same level, and they all comply with the standards: IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-57, and range between the predicate device K173436 and predicate device K191086. So the we can think that the slight differences in specification will not raise any safety or effectiveness issue.
Note 2:
Althouqh the "User Interface" of subject device is a little different from the predicate devices, but both predicate device and subject device have passed the evaluation complied with IEC 60601-1, these parameters are not impact on the safety and effectiveness, so we considered they are equivalent as the differences will not raise any safety or effectiveness issue.
Finial Conclusion:
The subject device "308nm Excimer System (model: XECL-308E)" is in the same design principle and utilizing identical Light Source (UV lamps) as the predicate devices. The "Indications for use" and technological characteristics (as Light Source, Wavelength, Delivery Method, Treatment area, Treatment time and Use Environment) are the same or similar to those of the predicate devices. So the subject device is Substantial Equivalent to the predicate devices K172237 and K191086.