(231 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the physical delivery of UVB light.
Yes
The device is described as being "intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma," which are medical conditions, and it emits UVB light known to be "beneficial in the treatment of various dermatological conditions."
No
The device description states that the Exciplex "is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma." It is a light-emitting device for therapy, not diagnosis.
No
The device description clearly states it is a "compact handheld excimer device" that emits UVB light, indicating it is a hardware device. The mention of "Software Verification" in the performance studies refers to the software component of the hardware device, not a standalone software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Exciplex is a light therapy device that delivers UVB light directly to the skin for treatment purposes. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states treatment of dermatological conditions, not diagnosis.
Therefore, based on the provided information, the Exciplex falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
The Exciplex is a compact handheld excimer device that emits a narrow-band UVB light at 308 nm. 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 5x5 cm² output window at an irradiance of 100 mW/cm². Treatments are performed by applying the output window over the affected area with the help of reduction tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light pulses 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)
Reprocessing validation: the reprocessing of the reduction tips and silicone masks was validated per AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
Software Verification: The software development and testing were executed in compliance to IEC 62304 Medical device software – Software life cycle processes and ISO 14971 Medical devices - Application of risk management to medical devices.
No clinical data were provided in order to demonstrate substantial equivalence.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
December 11, 2019
Clarteis % Lucie Dalet Regulatory Consultant Acknowledge Regulatory Strategies, LLC 2251 San Diego Ave. Suite B-257 San Diego, California 92110
Re: K191086
Trade/Device Name: Exciplex Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: April 23, 2019 Received: April 24, 2019
Dear Lucie Dalet:
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.
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 post-marketing 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 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-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) K191086
Device Name Exciplex
Indications for Use (Describe)
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.
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/2 description: The image shows the logo for CLARTEIS. The logo consists of the word "CLARTEIS" in black letters, with a blue and black circle to the left of the word. Below the word "CLARTEIS" is the phrase "Light For Skin Health" in smaller black letters, with a blue line above the phrase.
510(k) Summary K191086
DATE PREPARED
December 5, 2019
MANUFACTURER AND 510(k) OWNER
Clarteis WTC2, 120 route des macarons, 06 560 Valbonne, France Telephone: +33 609 990 440 Official Contact: Laurent Meilhac, Ph.D., CEO
REPRESENTATIVE/CONSULTANT
Lucie Dalet, Ph.D., Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: ldalet@acknowledge-rs.com, akomiyama@acknowledge-rs.com Website: www.AcKnowledge-RS.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Exciplex |
|---|---|
| Common Name: | Light, Ultraviolet, Dermatological |
| Regulation Number: | 21 CFR 878.4630 |
| Class: | II |
| Product Code: | FTC |
| Premarket Review: | ODE/DSD/General Surgery Devices Branch One (GSDB1) |
| Review Panel: | General & Plastic Surgery |
PREDICATE DEVICE IDENTIFICATION
The Exciplex is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K171702 | Exciplex308nm/ Clarteis | ✓ |
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION
The Exciplex is a compact handheld excimer device that emits a narrow-band UVB light at 308 nm. 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 5x5 cm² output window at an irradiance of 100 mW/cm². Treatments are performed by applying the output window over the affected area with the help of reduction tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light pulses where the device is used multiple times along the affected area.
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Image /page/4/Picture/3 description: The image shows the logo for CLARTEIS. The logo consists of a circle with a blue quarter in the upper left, followed by the text "CLARTEIS" in black. Below the text is a blue line, and below that is the text "Light For Skin Health" in a smaller font.
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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Clarteis believes that the Exciplex is substantially equivalent to the predicate device based on the information summarized here:
The subject device has identical design, dimensions and materials to the device cleared in K171702. The subject device has identical intended use and technological characteristics (light source, wavelength, treatment area size, fluence range) to the device cleared in K171702.
The main difference with the predicate device is the reprocessing of the existing silicone masks and reduction tips, whereas the predicate device components are provided for single-use only. Validation testing was conducted to ensure that the cleaning methods of the silicone masks and reduction tips are acceptable, and do not raise new issues of safety and effectiveness compared to the predicate device.
Minor software changes were also made to the subject device compared to the predicate device. These changes do not change the intended use of the device. Verification and validation testing were conducted to ensure that the software changes do not affect the safety and effectiveness of the subject device compared to the predicate device.
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Exciplex. The following tests were performed to demonstrate safety based on current industry standards:
Reprocessing validation: the reprocessing of the reduction tips and silicone masks was validated per AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
Software Verification: The software development and testing were executed in compliance to IEC 62304 Medical device software – Software life cycle processes and ISO 14971 Medical devices - Application of risk management to medical devices.
SUMMARY OF CLINICAL TESTING
No clinical data were provided in order to demonstrate substantial equivalence.
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510(k) Summary
Image /page/5/Picture/2 description: The image shows the logo for CLARTEIS. The logo consists of the word "CLARTEIS" in black, with a blue and black square to the left of the word. Below the word "CLARTEIS" is the phrase "Light For Skin Health" in a smaller font.
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CONCLUSION
Based on the test results, the similar indications for use, and the similar technological characteristics, the Exciplex is considered to be substantially equivalent to the predicate device.