Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware and basic software functionalities for treatment guidance and communication.

Therapeutic

Yes
The device is described as "intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI)," which clearly indicates a therapeutic purpose.

Diagnostic

No

The device is described as an "Ultraviolet Light Emitting Medical Device" intended for "localized phototherapeutic treatment" of dermatologic conditions. It delivers UVB light for therapy, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system includes a "Handheld UV light Emission device that delivers the UVB light," which is a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided text, the Clarify Medical Phototherapy System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's for "localized phototherapeutic treatment of dermatologic conditions." This is a therapeutic use, not a diagnostic one.
Device Description: The description focuses on delivering UVB light for treatment. It doesn't mention analyzing biological samples (blood, tissue, etc.) which is a key characteristic of IVDs.
Lack of IVD Keywords: The text does not contain keywords typically associated with IVDs such as "in vitro," "diagnostic," "assay," "sample analysis," "laboratory," etc.
Performance Studies: The performance studies described are related to the device's light output, power, software functionality, and safety, not the accuracy of a diagnostic test.

IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Clarify Medical Phototherapy System directly treats the patient's skin with light, which is a therapeutic action.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototheraputic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI).

Product codes (comma separated list FDA assigned to the subject device)

FTC

Device Description

The Clarify Phototherapy System is a handheld medical device that produces UVB light for the purpose of phototherapy. It was developed and will be marketed by Skylit Medical, Inc. DBA Clarify Medical, Inc. and is referred to herein as "Clarify Medical" or "Clarify". The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical device.

It is indicated 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 consists of the following components and accessories:

Handheld UV light Emission device that delivers the UVB light
Mobile Software Application that runs on smartphone (Android and iOS) platforms. This Application is the primary user interface, and provides patient guidance when phototherapy is delivered and treatment reminders
Physician Portal Software is a cloud based software application that links the patient to the prescribing physician during home therapy.

The Clarify System delivers UV light between the wavelengths of 300 and 320 nm using Light Emitting Diodes (LEDs). The handheld device is powered by a rechargeable battery and is connected to a smartphone software application that enables the device and provides feedback during treatment. The smartphone also provides reminders on treatment days and provides a means for patient feedback and dose adjustment. The smartphone application also provides the means for the patient to take photographs for comparison purposes.

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

Federal (U.S.) law restricts this device to sale by or on the order of a physician.
Home / Physician's office

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)

The determination of substantial equivalence is based on an assessment of non-clinical performance data.
Performance Tests: UBV light Source, Max Power Output; Power Source (Electrical Safety Testing, Battery Performance Testing); Prescription Stored on the device (System Validation); Treatment Reminders (Software Validation); Auto Calculation of treatment adjustment (System Validation); Skin Contact Materials (Performance testing); Wireless communications between handheld and console (System Validation); Records Retention (System Validation); Remote Physician Review of the results (System Validation).
All test results met Design Input Specifications and Demonstrated Equivalence.
Conclusion: Based on technical comparison, the Subject device has been shown to be 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.

K040062/K090097, K073587, K072035

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

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002

May 23, 2017

Skylit Medical Don Canal Vice President 401 North A Street Suite 775 San Diego, California 92101

Re: K170489

Trade/Device Name: Skylit Phototherapy System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: February 22, 2017 Received: February 23, 2017

Dear Don Canal:

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 Actinclude 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

1

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 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 -S

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) K170489

Device Name Clarify Medical Phototherapy System

Indications for Use (Describe)

The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototheraputic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI).

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)

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"510(k) Summary" as required by section 807.92(c)

Date Prepared:	May 22, 2017
Manufacturer Name	Clarify Medical, Inc.
401 N. A Street, Suite 775
San Diego, CA 92101, USA
Telephone: (972) 955-7644
Official Contact	Don Canal
Regulatory Affairs
401 N. A Street
San Diego, CA 92101, USA
Telephone:(972) 955-7644
Email: don@clarifymed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Clarify Phototherapy System
Common Name	Light, Ultraviolet, Dermatological
Classification Name
Classification Regulations	Ultraviolet lamp for dermatologic disorders
21 CFR
878.4630
Class II
Product Code	FTC
Submission Type	510(k)
Classification Panel
Premarket Review	General & Plastic Surgery
ODE/DSD/General Surgery Devices Branch One
(GSDB1)

Predicate Devices

The Clarify System is substantially equivalent to the other legally marketed phototherapy, UVB treatment devices. Specifically, the Clarify Phototherapy System is substantially equivalent to the Lerner Medical Inc. Levia Phototherapy System (K040062/K090097), Daavlin Distributing Co. DermaPal (K073587) and Allux, Inc. Resolve UVB Phototherapy System (K072035).

Device Description

The Clarify Phototherapy System is a handheld medical device that produces UVB light for the purpose of phototherapy. It was developed and will be marketed by Skylit Medical, Inc. DBA Clarify Medical, Inc. and is referred to herein as "Clarify Medical" or "Clarify". The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical device.

It is indicated for use in localized phototherapeutic treatment of dermatologic conditions

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such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI). The system consists of the following components and accessories:

Handheld UV light Emission device that delivers the UVB light 1.
1. Mobile Software Application that runs on smartphone (Android and iOS) platforms. This Application is the primary user interface, and provides patient guidance when phototherapy is delivered and treatment reminders
1. Physician Portal Software is a cloud based software application that links the patient to the prescribing physician during home therapy.

Federal (U.S.) law restricts this device to sale by or on the order of a physician.

The Clarify System delivers UV light between the wavelengths of 300 and 320 nm using Light Emitting Diodes (LEDs). The handheld device is powered by a rechargeable battery and is connected to a smartphone software application that enables the device and provides feedback during treatment. The smartphone also provides reminders on treatment days and provides a means for patient feedback and dose adjustment. The smartphone application also provides the means for the patient to take photographs for comparison purposes.

Indications for Use Statement

The system is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema). seborrheic dermatitis and leucoderma on all skin types (I-VI). The device can be used in the comfort of a patient's home or in a physician's office.

Comparison to Predicate Devices

The Clarify System is substantially equivalent to the other legally marketed phototherapy, UVB treatment devices. Specifically, the Clarify Phototherapy System is substantially equivalent to the Lerner Medical Inc. Levia Phototherapy System (K040062/K090097). Daavlin Distributing Co. DermaPal (K073587) and Allux, Inc. Resolve UVB Phototherapy System (K072035). The detailed comparison between the Subject Device and the Predicate devices is provided in Table 1 below.

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	Subject Device	Predicate Device	Predicate Device	Predicate Device
	Clarify Medical
Phototherapy System
(Subject Device)	Lerner Medical
Devices, Inc.
Levia Phototherapy
System / LH-75T
Phototherapy
System
K040062 / K090097	Daavlin Distributing
Co.
DermaPal K073587	Allux
Resolve
UVB
Photothera
py System
K072035
	Image: Clarify Medical Phototherapy System	Image: Levia Phototherapy System	Image: DermaPal K073587	Image unavailable
Indications
for Use	The Clarify Medical
Phototherapy 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).	K040062: The Levia
Phototherapy System is
intended for use in
UVB phototherapy for
the treatment of
psoriasis, vitiligo,
atopic dermatitis
(eczema), seborrheic
dermatitis and
leucoderma. The Levia
Phototherapy System is
intended for use on all
skin types (I-VI).

Table 1 – Predicate Comparison Table

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Summary of Performance Data – Bench

The determination of substantial equivalence is based on an assessment of non-clinical performance data. Table 2 below contains a summary of the performance testing that was submitted, referenced, or relied on in the premarket notification submission to determine substantial equivalence and how their results support a determination of substantial equivalence.

| Element of Comparison | Method for Safety
Assessment | Test Result Meet
Design Input
Specifications and
Demonstrate
Equivalence |
|---------------------------------------|---------------------------------|--------------------------------------------------------------------------------------|
| UBV light Source, Max Power
Output | Performance Testing | Yes |

Table 2 – Performance Test Summary

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| Element of Comparison | Method for Safety
Assessment | Test Result Meet
Design Input
Specifications and
Demonstrate
Equivalence |
|---------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Power Source | Electrical Safety Testing,
Battery Performance
Testing | Yes |
| Prescription Stored on the device | System Validation | Yes |
| Treatment Reminders | Software Validation | Yes |
| Auto Calculation of treatment
adjustment | System Validation | Yes |
| Skin Contact Materials | Performance testing | Yes |
| Wireless communications between
handheld and console | System Validation | Yes |
| Records Retention | System Validation | Yes |
| Remote Physician Review of the
results | System Validation | Yes |

Performance Test Conclusion

Based on technical comparison, the Subject device has been shown to be equivalent to the predicate devices.

Standards and Guidance Documents

Optical emissions testing:

Clarify has verified that optical emissions within the 300-320nm range is equivalent to that of the predicate devices. With the LEDs switched on, the optical emissions spectrum is measured at the treatment surface. The biologically weighted emissions curve is then computed using the International Commission on Illumination accepted erythema curve. Clarify has completed verification testing to demonstrate that the weighted peak of emissions is within the established therapeutic range (300-320nm). The optical power at the treatment surface is also measured to ensure it meets the specified requirements. The device has been evaluated for safety and performance in accordance with IEC 60601-2-57 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.

Electrical safety:

Clarify has completed testing to the applicable sections of IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, and IEC 60601-1-4 Medical electrical equipment – Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems.

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Software and wireless safety:

Due to the software component and wireless functionality of the device. Clarify will review and comply with the following FDA guidance documents: Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Issued 5/11/2005), Guidance for Industry and FDA Staff: Mobile Medical Applications (Issued 9/25/2013), and Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology in Medical Devices (Issued 8/13/2013). The following standard has been considered when evaluating the software: IEC 62304: Medical device software - Software life cycle processes.

Electromagnetic compatibility (EMC):

Since the system includes electronics, EMC has been assessed according to IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances.

Biocompatibility:

The distal end of the Clarify Phototherapy System will have limited contact duration (