Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a phototherapy system controlled by a smartphone app for treatment delivery and data storage. There is no mention of AI, ML, or image processing for analysis or decision-making. The physician determines the dose and frequency, not the device.

Therapeutic

Yes
The device is intended for "localized phototherapeutic treatment of dermatologic conditions" and its description states it is a "phototherapy system intended to treat dermatological conditions," indicating a therapeutic purpose.

Diagnostic

No
The device is described as a "phototherapy system intended to treat dermatological conditions," indicating a therapeutic rather than diagnostic function. It emits UV light for treatment and stores data about past treatments, but there is no mention of it analyzing patient data to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes a "light module" containing LEDs and a "device charger," in addition to the software application and phone. This indicates the presence of hardware components essential to the device's function.

IVD (In Vitro Diagnostic)

Based on the provided information, the LUMA™ Light System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the treatment of dermatologic conditions using light therapy. IVD devices are used to diagnose diseases or conditions by examining samples taken from the body (like blood, urine, or tissue).
Device Description: The device applies light directly to the skin for therapeutic purposes. It does not analyze biological samples.
Lack of IVD Characteristics: There is no mention of sample collection, analysis of biological markers, or diagnostic output.

The LUMA™ Light System is a therapeutic medical device that uses light for treatment, not a diagnostic device that analyzes samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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).

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

FTC

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.

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

Home / Physician 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)

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
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

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.

K170489

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

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

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);

1

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

2

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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2 510(k) Summary

Table 1: 510(k) Summary

| Submitter: | Luma Therapeutics
10 Rollins Rd Suite 120
Millbrae CA 94030 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Diage
Regulatory Affairs Consultant
Phone: 707.799.6732
E-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 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. |
| Indication for 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), seborrheic dermatitis, and leukoderma
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
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).	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).
Treatment Area	20.2 cm²	25.8 cm²
UVB Light Source	Same - LED lamps	LED lamps
User Interface	Touch screen on the Mobile
Device	Touch screen on Mobile Device
and a start button on the handheld
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)
with wireless connection to mobile
phone	Hand piece used with wireless
connection to mobile phone
	Physician sets frequency and
duration of treatments by
programming app in phone	Physician provides dosing
instructions and physician can
adjust time/dose based on the
treatment outcome
Increase UVB
treatment dose after
each treatment	Same - Yes this capability is built
into the software in accordance
with the prescribed protocol	Yes, this capability is built into the
SW in accordance with the
prescribed protocol
Delivery Method	Same - Treatment window	Spot treatment window
Power Source	Same – Rechargeable battery	Rechargeable battery
Prescription stored
on Device	Yes on mobile device	Yes – Cloud server
Use Environment	Same - Home / Physician Office	Home / Physician Office
IPX - Rating / water
resistance	Same - not water resistant	Not water resistant
Communications
between light
module and phone	Same - Bluetooth wireless	Bluetooth wireless
Records retention
and remote physician
review of results	Treatment records stored on phone	Yes, treatment data is stored and
uploaded to server for remote
review
Timer to control
treatment duration	Same - stored in the software
based on prescription	Yes - stored in the software, based
on Prescription
Software Application	Android	Android and iOS
Phone Provided with
System	Yes	No

Substantial Equivalence Comparison:

Premarket Notification for the Luma Light System

5

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

6

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.