Skylit Phototherapy System

K170489 · Skylit Medical · FTC · May 23, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170489
• Device Name: Skylit Phototherapy System
• Applicant: Skylit Medical
• Product Code: FTC · General, Plastic Surgery
• Decision Date: May 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

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).

Device Story

Handheld UV light-emitting diode (LED) device for localized phototherapy; delivers UVB light (300-320 nm). System includes handheld unit, mobile smartphone application (Android/iOS), and cloud-based physician portal. Physician prescribes treatment; patient uses handheld device at home or in clinic. Smartphone app serves as primary interface, providing treatment guidance, reminders, and dose adjustment based on physician protocol. Patient can capture photographs for comparison. Cloud portal links patient to physician for remote monitoring and data review. Device benefits patients by enabling home-based phototherapy with physician oversight, improving adherence and treatment management.

Clinical Evidence

Bench testing only. Performance testing verified optical emissions (300-320nm), electrical safety, battery performance, and biocompatibility (ISO 10993). System and software validation confirmed functionality of prescription storage, treatment reminders, auto-calculation of dose adjustments, and wireless communication. No clinical trial data presented.

Technological Characteristics

Handheld LED-based UVB source (300-320 nm); rechargeable battery; Bluetooth wireless connectivity. Surface-contact materials tested per ISO 10993. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-57 (non-laser light source), IEC 62304 (software lifecycle), IEC 62366 (usability).

Indications for Use

Indicated for localized phototherapeutic treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma in patients of all skin types (I-VI).

Regulatory Classification

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.

Predicate Devices

• Levia Phototherapy System (K040062/K090097)
• DermaPal (K073587)
• Resolve UVB Phototherapy System (K072035)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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

| Date Prepared: | May 22, 2017 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer Name | Clarify Medical, Inc.<br>401 N. A Street, Suite 775<br>San Diego, CA 92101, USA<br>Telephone: [phone] |
| Official Contact | Don Canal<br>Regulatory Affairs<br>401 N. A Street<br>San Diego, CA 92101, USA<br>Telephone:[phone]<br>Email: [e-mail] |

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | Clarify Phototherapy System |
|---------------------------------------------------|------------------------------------------------------------------------------------|
| Common Name | Light, Ultraviolet, Dermatological |
| Classification Name<br>Classification Regulations | Ultraviolet lamp for dermatologic disorders<br>21 CFR<br>878.4630<br>Class II |
| Product Code | FTC |
| Submission Type | 510(k) |
| Classification Panel<br>Premarket Review | General & Plastic Surgery<br>ODE/DSD/General Surgery Devices Branch One<br>(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.
- 2. 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
- 3. 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<br>Phototherapy System<br>(Subject Device) | Lerner Medical<br>Devices, Inc.<br>Levia Phototherapy<br>System / LH-75T<br>Phototherapy<br>System<br>K040062 / K090097 | Daavlin Distributing<br>Co.<br>DermaPal K073587 | Allux<br>Resolve<br>UVB<br>Photothera<br>py System<br>K072035 |
| | Image: Clarify Medical Phototherapy System | Image: Levia Phototherapy System | Image: DermaPal K073587 | Image unavailable |
| Indications<br>for Use | The Clarify Medical<br>Phototherapy System is<br>an Ultraviolet Light<br>Emitting Medical<br>device. It is intended<br>for use in localized<br>phototherapeutic<br>treatment of<br>dermatologic<br>conditions such as<br>psoriasis, vitiligo,<br>atopic dermatitis<br>(eczema), seborrheic<br>dermatitis and<br>leukoderma on all skin<br>types (I-VI). | K040062: The Levia<br>Phototherapy System is<br>intended for use in<br>UVB phototherapy for<br>the treatment of<br>psoriasis, vitiligo,<br>atopic dermatitis<br>(eczema), seborrheic<br>dermatitis and<br>leucoderma. The Levia<br>Phototherapy System is<br>intended for use on all<br>skin types (I-VI).<br><br>K090097: The LH-75T<br>Phototherapy System is<br>intended for use, by or<br>under the direction of a<br>physician, in UVB<br>phototherapy for the<br>treatment of psoriasis,<br>vitiligo, atopic<br>dermatitis (eczema),<br>seborrheic dermatitis<br>and leucoderma. The<br>LH-75T Phototherapy<br>System is intended for<br>use on all skin types (I<br>-VI). | The DermaPal® is a<br>handheld ultraviolet<br>light emitting<br>fluorescent lamp. It is<br>intended for use, by or<br>under the direction of a<br>physician, for the<br>treatment of psoriasis,<br>vitiligo, and atopic<br>dermatitis (eczema) on<br>all skin types (I - VI). | The Resolve™ UVB<br>Phototherapy System is<br>an ultraviolet light<br>emitting medical device<br>for localized<br>phototherapeutic<br>treatment of<br>dermatologic conditions<br>such as psoriasis,<br>vitiligo, atopic<br>dermatitis (eczema),<br>and seborrheic<br>dermatitis. The<br>Resolve™ UVB<br>Phototherapy System is<br>intended to be used<br>with all Skin Types (I -<br>VI). |
| Product Codes<br>/ Regulation<br>Number | FTC / 21 CFR<br>878.4630 | FTC / 21 CFR<br>878.4630 | FTC / 21 CFR<br>878.4630 | FTC / 21 CFR<br>878.4630 |
| Treatment<br>area | $4.5 cm^2$ | $3 cm^2$ | 11.4 x 2.54 cm | 12.8 x 9.0 cm |
| | Subject Device | Predicate Device | Predicate Device | Predicate Device |
| | Clarify Medical<br>Phototherapy System<br>(Subject Device) | Lerner Medical<br>Devices, Inc.<br>Levia Phototherapy<br>System / LH-75T<br>Phototherapy<br>System<br>K040062 / K090097 | Daavlin Distributing<br>Co.<br>DermaPal K073587 | Allux<br>Resolve<br>UVB<br>Photothera<br>py System<br>K072035 |
| UVB light<br>source | LED UV lamps | Arc Lamp | Fluorescent UV lamps | LED UV lamps |
| User<br>Interface | Touch screen on<br>Mobile Device and<br>Start button on | Control Box with<br>cables to handheld<br>device | Control Box with<br>cables to handheld<br>device | Control Box with<br>cables to handheld<br>device |
| Max Power<br>Output | 3-15 mW/cm2 | 90-100 mW/ cm2 | 3.9-6.8 mW/ cm2 | 1 mW/cm2 |
| UV light<br>Wavelength | 300-320 nm | 300-320 nm | 300-320 nm | 300-320nm |
| Mode of<br>operation | Hand piece used with<br>wireless connection<br>to mobile phone | Hand piece<br>connected to console<br>with touch screen<br>control panel to<br>control treatment | Hand piece used in<br>standalone treatment<br>mode | Patient attached<br>unit connected<br>to a power<br>supply used in<br>standalone<br>treatment mode |
| | Physician<br>provides dosing<br>instructions and<br>physician can<br>adjust time/dose<br>based on | Physician provides<br>dosing instructions<br>and patient can<br>adjust time/dose<br>based on treatment<br>outcome | Physician provides<br>dosing instructions<br>and patient can<br>adjust time/dose<br>based on treatment<br>outcome | Unknown |
| Increase UVB<br>treatment Dose<br>after each<br>treatment | Yes, this<br>capability is built<br>into the SW in<br>accordance with<br>the prescribed<br>protocol. | Yes, this capability<br>is built into the SW<br>in accordance with<br>the prescribed<br>protocol. | Instructions are<br>provided in the<br>DFU. Not built into<br>the the SW, the<br>patient must<br>manually calculate<br>and enter the dose. | Unknown |
| Delivery<br>method | Spot treatment window | Spot treatment attachment<br>(LiteSpot™), Quartz fiber-<br>optic brush attachment<br>(LiteBrush™) | Spot treatment wand with<br>integrated comb | Spot treatment window |
| Power<br>Source | Rechargeable battery | AC outlet | AC outlet | AC outlet |
| Prescription<br>stored on<br>Device | Yes - Cloud server | Yes - USB | No | No |
| Scalp<br>Attachment | No | Yes | Yes | No |
| Use<br>Environme | Home / Physician's<br>office | Home / Physician's<br>office | Home / Physician's<br>office | Home / Physician's<br>office |
| | Subject Device | Predicate Device | Predicate Device | Predicate Device |
| | Clarify Medical<br>Phototherapy System<br>(Subject Device) | Lerner Medical<br>Devices, Inc.<br>Levia Phototherapy<br>System / LH-75T<br>Phototherapy<br>System<br>K040062 / K090097 | Daavlin Distributing<br>Co.<br>DermaPal K073587 | Allux<br>Resolve<br>UVB<br>Photothera<br>py System<br>K072035 |
| IPX -<br>Rating/water<br>Resistance | Not water resistant | Not water resistant | Not water resistant | Not water resistant |
| Communications<br>between | Bluetooth wireless | Wired connection | Wired connection | Wired connection |
| Records<br>retention<br>and remote<br>physician<br>review of<br>results. | Yes. Treatment data is<br>stored and uploaded to<br>Server for remote<br>review | Yes. Treatment data is<br>stored locally on the<br>device. no remote<br>review of data is<br>possible | No record retention<br>capability | No record retention<br>capability |
| Treatment<br>day/Time<br>reminder<br>set by User | Yes | No | No | No |
| Timer to<br>control<br>treatment<br>duration | Yes - stored in the<br>Software, based on<br>Prescription | Yes - entered by the<br>user for each treatment | Yes - entered by the<br>user for each treatment | Yes - entered by the<br>user for each treatment |
| Target<br>Population | Patients and clinicians | Patients and<br>clinicians | Patients and<br>clinicians | Patients and<br>clinicians |

# 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<br>Assessment | Test Result Meet<br>Design Input<br>Specifications and<br>Demonstrate<br>Equivalence |
|---------------------------------------|---------------------------------|--------------------------------------------------------------------------------------|
| UBV light Source, Max Power<br>Output | Performance Testing | Yes |

# Table 2 – Performance Test Summary

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| Element of Comparison | Method for Safety<br>Assessment | Test Result Meet<br>Design Input<br>Specifications and<br>Demonstrate<br>Equivalence |
|---------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Power Source | Electrical Safety Testing,<br>Battery Performance<br>Testing | Yes |
| Prescription Stored on the device | System Validation | Yes |
| Treatment Reminders | Software Validation | Yes |
| Auto Calculation of treatment<br>adjustment | System Validation | Yes |
| Skin Contact Materials | Performance testing | Yes |
| Wireless communications between<br>handheld and console | System Validation | Yes |
| Records Retention | System Validation | Yes |
| Remote Physician Review of the<br>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 (< 24 hours) with skin and is therefore considered a "surface device" according to Annex A of ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Based on the device type and contact duration, FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," recommends the following biocompatibility tests be performed: cytotoxicity, sensitization, and irritation. The Clarify Device distal end material has been tested to ISO-10993.

# Human factors:

Clarify medical has completed numerous formative studies and software validation of the Clarify System. Clarify medical will not market the device until compliance with IEC 62366: Medical devices – Application of usability engineering to medical devices is verified by an independent third party.

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