Luma Light System

K173436 · Luma Therapeutics · FTC · Jan 30, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173436
• Device Name: Luma Light System
• Applicant: Luma Therapeutics
• Product Code: FTC · General, Plastic Surgery
• Decision Date: Jan 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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), sebhoic dermatitis, and leukoderma on all skin types (I-VI).

Device Story

Luma Light System is a home-use phototherapy device for localized treatment of dermatologic conditions. Input: physician-prescribed treatment parameters (dose/frequency). Operation: light module containing narrowband UVB LEDs (300-320 nm) attaches to a dressing on the patient's skin; module communicates via Bluetooth with an Android smartphone app. The app manages treatment delivery, provides reminders, and stores treatment history. Physician determines dosing; patient operates the device at home. Output: controlled narrowband UVB light exposure. Benefit: enables patient-administered phototherapy for chronic skin conditions, reducing need for clinic visits while maintaining physician oversight via programmed protocols.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through software, electrical, and mechanical testing per IEC 60601-1, EN 60601-1-2, and IEC 60601-2-57 standards.

Technological Characteristics

Narrowband UVB LED light source (300-320 nm); 20.2 cm² treatment area; 4.2–7.2 mW/cm² power output. Rechargeable battery-powered. Bluetooth wireless connectivity to Android mobile device. Software-controlled dosing and timer. Complies with IEC 60601-1 (safety), EN 60601-1-2 (EMC), and IEC 60601-2-57 (non-laser light source).

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

• Skylit Phototherapy System (K170489)

Submission Summary (Full Text)

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January 30, 2018

Luma Therapeutics Tiffini Wittwer Regulatory 10 Rollins Rd Suite 120 Millbrae, California 94030

Re: K173436

Trade/Device Name: Luma Light System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: November 1, 2017 Received: November 3, 2017

Dear Tiffini Wittwer:

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, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerelv. Jennifer R. Stevenson -53 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) K173436

Device Name Luma Light System

Indications for Use (Describe)

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), sebhoic dermatitis, and leukoderma on all skin types (I-VI).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <div><span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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### 2 510(k) Summary

# Table 1: 510(k) Summary

| Submitter: | Luma Therapeutics<br>10 Rollins Rd Suite 120<br>Millbrae CA 94030 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Diage<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>E-mail: [e-mail] |
| Date Of Submission: | November 1, 2017 |
| Trade Name: | Luma Light System |
| Common Name: | Ultraviolet Lamp for Dermatologic Disorders |
| Classification: | Class II, per 21 CFR 878.4630 |
| Product Code: | FTC |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>• K170489 – Skylit Phototherapy System |
| Device Description: | The Luma Light System is a phototherapy system intended to treat<br>dermatological conditions such as psoriasis. The system includes a<br>light module, an Android Nexus 4 phone, a software-based phone<br>application (app), and a device charger. The light module contains<br>light emitting diodes (LEDs), which create an array of narrowband<br>UVB light centered at a wavelength between 300 - 320 nm. The<br>light module attaches to a dressing applied to the patient's affected<br>skin to allow for passive dosing of the lesion. This is a home use<br>device intended to be used and operated by the patient (see technical<br>specifications for environmental limitations). A physician will<br>determine the dose and frequency of treatment. The app is then used<br>by the patient to deliver treatments, provide treatment reminders and<br>store data about prior treatments. |
| Indication for Use: | The LUMA™ Light System is an Ultraviolet Light Emitting<br>Medical Device. It is intended for use in localized phototherapeutic<br>treatment of dermatologic conditions such as psoriasis, vitiligo,<br>atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma<br>on all skin types (I-VI). |

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| Characteristics | Luma Light System | Clarify Phototherapy System |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Luma Therapeutics | Skylit Phototherapy |
| 510(k) Number | TBD | K170489 |
| Classification | Class II | Class II |
| Product Code | FTC | FTC |
| Regulation | 21 CFR 878.4630 | 21 CFR 878.4630 |
| Indications for Use | The LUMA™ System is an<br>Ultraviolet Light Emitting Medical<br>Device. It is intended for use in<br>localized phototherapeutic<br>treatment of dermatologic<br>conditions such as psoriasis,<br>vitiligo, atopic dermatitis<br>(eczema), seborrheic dermatitis,<br>and leukoderma on all skin types<br>(I-VI). | The Clarify Medical Phototherapy<br>System is an Ultraviolet Light<br>Emitting Medical Device. It is<br>intended for use in localized<br>phototherapeutic treatment of<br>dermatologic conditions such as<br>psoriasis, vitiligo, atopic dermatitis<br>(eczema), seborrheic dermatitis,<br>and leukoderma on all skin types<br>(I-VI). |
| Treatment Area | 20.2 cm² | 25.8 cm² |
| UVB Light Source | Same - LED lamps | LED lamps |
| User Interface | Touch screen on the Mobile<br>Device | Touch screen on Mobile Device<br>and a start button on the handheld<br>unit |
| Max Power Output | 4.2 – 7.2 mW/cm² | 3-15 mW/cm² |
| UV light Wavelength | Same - 300 - 320 nm | 300 – 320 nm |
| Mode of operation | Same - Hand piece (light module)<br>with wireless connection to mobile<br>phone | Hand piece used with wireless<br>connection to mobile phone |
| | Physician sets frequency and<br>duration of treatments by<br>programming app in phone | Physician provides dosing<br>instructions and physician can<br>adjust time/dose based on the<br>treatment outcome |
| Increase UVB<br>treatment dose after<br>each treatment | Same - Yes this capability is built<br>into the software in accordance<br>with the prescribed protocol | Yes, this capability is built into the<br>SW in accordance with the<br>prescribed protocol |
| Delivery Method | Same - Treatment window | Spot treatment window |
| Power Source | Same – Rechargeable battery | Rechargeable battery |
| Prescription stored<br>on Device | Yes on mobile device | Yes – Cloud server |
| Use Environment | Same - Home / Physician Office | Home / Physician Office |
| IPX - Rating / water<br>resistance | Same - not water resistant | Not water resistant |
| Communications<br>between light<br>module and phone | Same - Bluetooth wireless | Bluetooth wireless |
| Records retention<br>and remote physician<br>review of results | Treatment records stored on phone | Yes, treatment data is stored and<br>uploaded to server for remote<br>review |
| Timer to control<br>treatment duration | Same - stored in the software<br>based on prescription | Yes - stored in the software, based<br>on Prescription |
| Software Application | Android | Android and iOS |
| Phone Provided with<br>System | Yes | No |

# Substantial Equivalence Comparison:

Premarket Notification for the Luma Light System

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## Performance Testing / Safety and Effectiveness:

To verify that device design meets its functional and performance requirements, representative samples of the device underwent software, electrical, and mechanical testing in accordance with the following industry standards.

- . IEC-60601-1 › Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- EN-60601-1-2 › Medical Electrical Equipment. General Requirements for Basic Safety . and Essential Performance. Collateral Standard. Electromagnetic Compatibility. Requirements and Tests

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- 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.
- IEC 62304: Medical device software – Software life cycle processes.
- Guidance for Industry and FDA Staff: .
- Guidance for the Content of Premarket Submissions for Software Contained in O Medical Devices (Issued 5/11/2005),
- Mobile Medical Applications (Issued 9/25/2013) O
- Radio Frequency Wireless Technology in Medical Devices (Issued 8/13/2013). O

# Conclusion:

The LUMA system has similar indications for use, principles of operation, and fundamental technological characteristics as compared to the predicate. Both devices are used for treating dermatological skin conditions with Ultraviolet light emitted from a LED light source. In addition, both devices have similar user interface. Any differences in product performance or features have been validated to ensure the LUMA system performs as intended and does not raise any new issues of safety and effectiveness as compared to the predicate device. Based on this information as well as documentation in support of the LUMA system, Luma Therapeutics believes the LUMA system is substantially equivalent to the predicate device.