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 Description

The Luma Light System is a phototherapy system intended to treat dermatological conditions such as psoriasis. The system includes a light module, an Android Nexus 4 phone, a software-based phone application (app), and a device charger. The light module contains light emitting diodes (LEDs), which create an array of narrowband UVB light centered at a wavelength between 300 - 320 nm. The light module attaches to a dressing applied to the patient's affected skin to allow for passive dosing of the lesion. This is a home use device intended to be used and operated by the patient (see technical specifications for environmental limitations). A physician will determine the dose and frequency of treatment. The app is then used by the patient to deliver treatments, provide treatment reminders and store data about prior treatments.

AI/ML Overview

The provided text describes the Luma Light System, a phototherapy device for dermatological conditions, and its substantial equivalence to a predicate device (Skylit Phototherapy System, K170489). However, it does not contain specific acceptance criteria, reported device performance metrics in numerical form, or details about a study designed to prove the device meets acceptance criteria using a test set with ground truth.

The document primarily focuses on establishing substantial equivalence based on similar indications for use, principles of operation, fundamental technological characteristics, and user interface compared to the predicate device. It lists general performance testing conducted to verify functional and performance requirements but does not provide results.

Therefore, many of the requested details cannot be extracted from this document as they are not present.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that the device underwent "software, electrical, and mechanical testing in accordance with the following industry standards" to "verify that device design meets its functional and performance requirements." However, it does not specify what those functional and performance acceptance criteria were (e.g., minimum power output, wavelength accuracy, duration consistency) nor does it report the actual performance results obtained from these tests in a quantifiable manner.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document mentions "representative samples of the device underwent software, electrical, and mechanical testing," but it does not specify the sample size of these devices, the type of data provenance, or if there was a separate "test set" for performance evaluation against acceptance criteria as might be done for an AI/algorithm-driven device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. This question is highly relevant to studies involving AI or diagnostic devices where human expert consensus is used to establish ground truth for evaluating performance. The Luma Light System is a phototherapy treatment device, not a diagnostic one or an AI algorithm for interpreting data. The document describes performance testing of the device hardware/software, not a clinical study involving human readers or a ground truth established by experts in the context of diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. Similar to point 3, this is relevant to studies evaluating diagnostic accuracy, often with human interpretation. This document does not describe such a study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This type of study (MRMC, AI assistance) is not applicable to the Luma Light System as described. It is a phototherapy device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided. While the device has an app and software, the performance testing mentioned is for the device's functional integrity as a phototherapy system (electrical, mechanical, software adherence to standards), not for a standalone diagnostic algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. As the document describes engineering verification testing (software, electrical, mechanical) rather than a clinical accuracy study, the concept of "ground truth" as typically applied in diagnostic or AI evaluations is not present. The "ground truth" for the engineering tests would be the specified requirements and standards themselves.

8. The sample size for the training set

Cannot be provided. This information pertains to machine learning models. The Luma Light System is a hardware device with an app, not explicitly described as using a machine learning model that requires a distinct "training set." The software mentioned is for delivering treatments, providing reminders, and storing data, not for learning or making diagnostic predictions.

9. How the ground truth for the training set was established

Cannot be provided. As there's no mention of a training set for an AI model, this question is not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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2 510(k) Summary

Table 1: 510(k) Summary

Submitter:	Luma Therapeutics10 Rollins Rd Suite 120Millbrae CA 94030
Contact Person:	Tiffini DiageRegulatory Affairs ConsultantPhone: 707.799.6732E-mail: tdiage@raechelon.com
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:• K170489 – Skylit Phototherapy System
Device Description:	The Luma Light System is a phototherapy system intended to treatdermatological conditions such as psoriasis. The system includes alight module, an Android Nexus 4 phone, a software-based phoneapplication (app), and a device charger. The light module containslight emitting diodes (LEDs), which create an array of narrowbandUVB light centered at a wavelength between 300 - 320 nm. Thelight module attaches to a dressing applied to the patient's affectedskin to allow for passive dosing of the lesion. This is a home usedevice intended to be used and operated by the patient (see technicalspecifications for environmental limitations). A physician willdetermine the dose and frequency of treatment. The app is then usedby the patient to deliver treatments, provide treatment reminders andstore data about prior treatments.
Indication for Use:	The LUMA™ Light System is an Ultraviolet Light EmittingMedical Device. It is intended for use in localized phototherapeutictreatment of dermatologic conditions such as psoriasis, vitiligo,atopic dermatitis (eczema), seborrheic dermatitis, and leukodermaon 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 anUltraviolet Light Emitting MedicalDevice. It is intended for use inlocalized phototherapeutictreatment of dermatologicconditions such as psoriasis,vitiligo, atopic dermatitis(eczema), seborrheic dermatitis,and leukoderma on all skin types(I-VI).	The Clarify Medical PhototherapySystem is an Ultraviolet LightEmitting Medical Device. It isintended for use in localizedphototherapeutic treatment ofdermatologic conditions such aspsoriasis, vitiligo, atopic dermatitis(eczema), seborrheic dermatitis,and leukoderma on all skin types(I-VI).
Treatment Area	20.2 cm²	25.8 cm²
UVB Light Source	Same - LED lamps	LED lamps
User Interface	Touch screen on the MobileDevice	Touch screen on Mobile Deviceand a start button on the handheldunit
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)with wireless connection to mobilephone	Hand piece used with wirelessconnection to mobile phone
	Physician sets frequency andduration of treatments byprogramming app in phone	Physician provides dosinginstructions and physician canadjust time/dose based on thetreatment outcome
Increase UVBtreatment dose aftereach treatment	Same - Yes this capability is builtinto the software in accordancewith the prescribed protocol	Yes, this capability is built into theSW in accordance with theprescribed protocol
Delivery Method	Same - Treatment window	Spot treatment window
Power Source	Same – Rechargeable battery	Rechargeable battery
Prescription storedon Device	Yes on mobile device	Yes – Cloud server
Use Environment	Same - Home / Physician Office	Home / Physician Office
IPX - Rating / waterresistance	Same - not water resistant	Not water resistant
Communicationsbetween lightmodule and phone	Same - Bluetooth wireless	Bluetooth wireless
Records retentionand remote physicianreview of results	Treatment records stored on phone	Yes, treatment data is stored anduploaded to server for remotereview
Timer to controltreatment duration	Same - stored in the softwarebased on prescription	Yes - stored in the software, basedon Prescription
Software Application	Android	Android and iOS
Phone Provided withSystem	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.

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.