(127 days)
Not Found
No
The summary describes a light therapy device and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the "treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma," which are medical conditions, and it emits UVB light known to be beneficial for these treatments.
No
The device is described as being "intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is a "compact handheld excimer device that emits a narrow-band UVB light at 308nm," indicating it is a hardware device that delivers light therapy. While it mentions software verification, this is for the software controlling the hardware, not a standalone software medical 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 dermatological conditions (psoriasis, vitiligo, atopic dermatitis, and leukoderma) by applying light to the affected area. IVDs are used to diagnose diseases or conditions by examining samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a handheld excimer device that emits UVB light for therapeutic purposes. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of sample collection, analysis of biological markers, or any diagnostic function.
The device is a therapeutic device used for light therapy, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Exciplex308nm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Product codes (comma separated list FDA assigned to the subject device)
FTC, GEX
Device Description
The Exciplex 308m" is a compact handheld excimer device that emits a narrow-band UVB light at 308nm. This ultraviolet wavelength of light is known to be beneficial in the treatment of various dermatological conditions such as psoriasis and vitiligo. The UVB light is homogeneously delivered through a 5x5cm² output window at an irradiance of 100mW/cm². Treatments are performed by applying the output window over the affected area with the help of treatment tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light "shots" where the device is used multiple times along the affected area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
No FDA performance standards have been established for the Exciplex 38000. The following tests were performed to demonstrate safety based on current industry standards:
Software Verification: The software development and testing was executed in compliance to IEC 60601-1, IEC 62304 and ISO 14971.
Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to IEC 60601-1, IEC60601-1-2 and IEC 60601-2-57.
Performance and usability testing: The subject device was tested in compliance to IEC 62471, IEC 62366-1 and IEC 60601-1-6.
The results of these tests indicate that the Exciplex3080™ is substantially equivalent to the predicate devices.
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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October 13, 2017 Clarteis % Allison Komiyama, Ph.D., RAC AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, California 92104
Re: K171702
Trade/Device Name: Exciplex308nm Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC, GEX Dated: September 18, 2017 Received: September 19, 2017
Dear Dr. Komiyama:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S3
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) K171702
Device Name Exciplex308nm
Indications for Use (Describe)
The Exciplex308nm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Clarteis
510(k) Summary K171702
DATE PREPARED
October 13, 2017
MANUFACTURER AND 510(k) OWNER
Clarteis, SAS WTC2, 120 route des macarons, 60 560 Valbonne, France Telephone: Official Contact: Laurent Meilhac, Ph.D., CEO
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
Exciplex308nm
COMMON NAME
Light, Ultraviolet, Dermatological
DEVICE CLASSIFICATION
Ultraviolet lamp for dermatologic disorders (21 CFR 878.4630, FTC, Class II)
PREMARKET REVIEW
ODE/DSD/General Surgery Devices Branch One (GSDB1) General & Plastic Surgery
INDICATIONS FOR USE
The Exciplex3080mm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
DEVICE DESCRIPTION
The Exciplex 308m" is a compact handheld excimer device that emits a narrow-band UVB light at 308nm. This ultraviolet wavelength of light is known to be beneficial in the treatment of various dermatological conditions such as psoriasis and vitiligo. The UVB light is homogeneously
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Image /page/4/Picture/1 description: The image shows a logo for a company or brand named "Clarteis". The logo consists of two parts: a rounded square with a white circle inside, and the name "Clarteis" written in a cursive font. The logo is green.
delivered through a 5x5cm² output window at an irradiance of 100mW/cm². Treatments are performed by applying the output window over the affected area with the help of treatment tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light "shots" where the device is used multiple times along the affected area.
PREDICATE DEVICE IDENTIFICATION
The Exciplex3080mm is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K073066 | Model 308 Dermatological Excimer System / Quantel | |
| Medical, Inc. | ✓ | |
| K150752 | GME ExSys 308 / GME German Medical Engineering GmbH | |
| K051428 | VTRAC Excimer Lamp System / PhotoMedex, Inc. |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Exciplex 38000. The following tests were performed to demonstrate safety based on current industry standards:
Software Verification: The software development and testing was executed in compliance to IEC 60601-1, IEC 62304 and ISO 14971.
Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to IEC 60601-1, IEC60601-1-2 and IEC 60601-2-57.
Performance and usability testing: The subject device was tested in compliance to IEC 62471, IEC 62366-1 and IEC 60601-1-6.
The results of these tests indicate that the Exciplex3080™ is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Clarteis believes that the Exciplex 388m : is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design and dimensions, and uses similar materials as the device cleared in K073066. The subject device has the same intended use and similar technological characteristics (light source, wavelength, treatment area size, fluence range) to the devices cleared in K073066, K150752, and K051428. Any differences in technological characteristics do not raise different questions of safety and effectiveness and performance data demonstrate substantial equivalence to the predicates.
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Image /page/5/Picture/1 description: The image shows a logo with a green square with rounded corners and a white circle inside. To the right of the square is the word "Clarteis" written in a cursive font, also in green. The logo appears to be for a company or organization named Clarteis.
CONCLUSION
Based on the testing performed, including irradiance uniformity, ability of the masks and tips to block UV light, classification of the UV lamp, and software and hardware verification testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Exciplex380m" are assessed to be substantially equivalent to the predicate devices.