The dpl® SpectraLite system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles within the periorbital region. The device uses four types of LEDs: 605nm amber, 625nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required. The dpl® SpectraLite system components include the device containing the LED module, USB charging cord, and a storage case. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over The Counter (OTC).

AI/ML Overview

The provided text is a 510(k) Summary for the dpl® SpectraLite device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for the new device's clinical efficacy in treating wrinkles.

Therefore, many of the requested data points, particularly those related to clinical performance, ground truth, expert adjudication, and sample sizes for effectiveness studies, are not explicitly available in this submission. The submission primarily addresses safety, technological characteristics compared to the predicate, and usability.

However, I can extract information related to safety, usability, and the general approach of the substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for the clinical performance of this device as a medical treatment (i.e., its effectiveness in reducing wrinkles) is not directly addressed in this 510(k) summary in the way a clinical trial would define it. Instead, the focus is on demonstrating substantial equivalence to a legally marketed predicate device (dpl® Nüve for Wrinkles) in terms of its intended use, technological characteristics, and safety profiles.

The "performance" reported primarily relates to safety and functional aspects, rather than direct measurements of wrinkle reduction from a standalone clinical trial of the dpl® SpectraLite.

Here's a table based on the information provided, interpreting "acceptance criteria" as compliance with standards and successful usability testing, and "reported device performance" as the documented outcomes of those tests:

Acceptance Criteria (Implied from testing)	Reported Device Performance
Compliance with Medical Electrical Equipment (Basic Safety and Essential Performance - IEC 60601-1)	Yes, the dpl® SpectraLite system conforms to IEC 60601-1.
Compliance with Photobiological Safety (IEC 62471)	Yes, the dpl® SpectraLite system conforms to IEC 62471.
Compliance with Electromagnetic Compatibility (IEC 60601-1-2)	Yes, the dpl® SpectraLite system conforms to IEC 60601-1-2.
Software Validation (in accordance with FDA guidance)	Yes, the dpl® SpectraLite system software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices".
Usability Testing: Ability to perform light sensitivity test	100% of participants were able to demonstrate the light sensitivity test.
Usability Testing: Ability to use the device successfully	100% of participants were able to use the device successfully.
Biocompatibility (US FDA 21 CFR 177.1810 for Styrene block polymers – TPE Test)	Yes, tested against US FDA 21 CFR 177.1810, and no new biocompatibility issues are introduced with the addition of TPE Silicone.
Substantial Equivalence to Predicate Device (K141181) for intended use, output, wavelengths, treatment duration, and regimen	"No significant differences exist between the subject device and predicate, and no different questions of safety and effectiveness arise." The device has the same intended use (treatment of wrinkles), similar output (61.59 mW/cm² vs 62.07 mW/cm²), same number of wavelengths (4), same treatment duration (3 minutes), and same regimen (5 days/week for 8 weeks).

Study Details

Sample size used for the test set and the data provenance:
- Usability Study: 15 participants.
- Data Provenance: Not specified, but likely prospective for the usability study. The submission itself is dated July 4, 2017, and refers to testing performed by LED Technologies, Inc.
- For the core claim of substantial equivalence regarding effectiveness, the "test set" is essentially the comparison between the new device's specifications and the predicate device's established performance, rather than a separate clinical trial test set for the new device's efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided for clinical effectiveness. The usability study involved participants, not "experts" establishing a clinical ground truth for wrinkle reduction. The claim of effectiveness is derived from equivalence to the predicate, whose effectiveness would have been established previously.
Adjudication method for the test set:
- Not applicable / Not provided for clinical effectiveness. The usability study's success rates (100%) suggest direct observation or self-reporting, rather than a complex adjudication process.
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:
- No, a MRMC comparative effectiveness study was not done. This device is an LED-based therapeutic device, not an AI-powered diagnostic imaging device that would involve human readers or AI assistance in interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the typical sense. This device is a therapeutic device, not an "algorithm." Its performance is its light emission properties and how it's used. The primary "standalone" performance testing mentioned refers to functional and safety compliance (e.g., electrical safety, photobiological safety).
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For safety and functional performance: Ground truth is established by engineering specifications, international consensus standards (IEC), and FDA guidance for software and biocompatibility.
- For usability: Ground truth is based on participant successful completion of tasks (light sensitivity test, using the device).
- For clinical effectiveness (wrinkle reduction): The ground truth for the dpl® SpectraLite is assumed to be equivalent to the predicate device (dpl® Nüve for Wrinkles), which had already established its effectiveness. The submission does not provide new effectiveness outcome data for the dpl® SpectraLite.
The sample size for the training set:
- Not applicable / Not provided. This device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense.
How the ground truth for the training set was established:
- Not applicable / Not provided. As it's not an AI/machine learning device, there's no training set or associated ground truth establishment process in that context.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7. 2017

LED Technologies, Inc. Jelena Barbaric Compliance Manager 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village, Colorado 80111

Re: K171386

Trade/Device Name: dpl SpectraLite Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS Dated: May 12, 2017 Received: June 5, 2017

Dear Jelena Barbaric:

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 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 -S3

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K171386

Device Name

dpl® SpectraLite

Indications for Use (Describe)

The dpl@ SpectraLite is an Over-the-Counter (OTC) device intended for use in treating wrinkles within periorbital region.

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

Submission Date: July 4, 2017

1. Submitter Information:	LED Technologies, Inc. – Jelena Barbaric
	6000 Greenwood Plaza Blvd., Suite 110
	Greenwood Village, CO 80111
	Tel: 303-407-6882
	Email: jbarbaric@ledtechnologies.com
For Specification Developer:	LED Technologies, Inc.
	Attn: Lloyd Nelson
	6000 Greenwood Plaza Blvd., Suite 110
	Greenwood Village, CO, 80111

Email: Inelson@ledtechnologies.com

2. General Information

2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction
2.2 Common/usual name: dpl® SpectraLite
2.3 Proprietary Names: dpl® SpectraLite
2.4 Classification: Class II
2.5 Classification Number: 878.4810
2.6 Product Code OHS
2.7 Regulation Medical Specialty: General & Plastic Surgery
2.8 Review Panel: Office of Device Evaluation (ODE) Division of Surgical Devices (DSD) General Surgery Device Branch One - Light Based/Laser (GSDB1)

3. Device Description

The dpl® SpectraLite system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles within the periorbital region. The

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device uses four types of LEDs: 605nm amber, 625nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required.

The dpl® SpectraLite system components include the device containing the LED module, USB charging cord, and a storage case.

The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Ove The Counter (OTC).

4. Indications/Intended Use:

The dpl® SpectraLite is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.

Rx or OTC:

The dpl® SpectraLite is an Over-the Counter device. The labeling, instructions, and User Operations (21 CFR § 801.60 and 61), are design for layman understanding and use. The predicate device is OTC.

5. Predicate Device:

This device is substantially equivalent to the following predicate, which is currently in safe and effective commerce under product code OHS:

K141181 - dpl® Nuve for Wrinkles (LED Technologies, Inc.)

Device	dpl® SpectraLiteLED Technologies, Inc.KXXXXXXXXThis Submission	dpl® Nüve for WrinklesLED Technologies, Inc.K141181A Predicate Device
Indications	The dpl® SpectraLite is anOver-the-Counter (OTC)device intended for the usein treating wrinkles withinperiorbital region.	The dpl® Nüve for Wrinkles isan Over-the-Counter (OTC)device intended for the usein treating full-face wrinkles.
Wavelengths	605 nm, 625 nm, 660nm,880 nm	605 nm, 625 nm, 660nm,880 nm
Modes	On/Off	On/Off

Predicate Chart

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Irradiance Source	LED	LED
Visible light LEDs	Yes	Yes
Treatment Area	28 cm²	30 cm²
Energy Level	61.59 mW/cm²	62.07 mW/cm²
Power Supply	120-240V 5VDC PowerAdapter	120-240V AC Power Adapter
Treatment Time	3 minutes per treatment	3 minutes per treatment
Target Population	Individuals with wrinkles ontheir face within theperiorbital region.	Individuals with wrinkles ontheir face.
Location for Use	OTC	OTC

Summary of the technological characteristics of the device compared to predicate device:

1. Has the same intended use as the predicate device (I.e., treatment of wrinkles);
1. Has the same/similar output (i.e., 62 mW/cm²) as the predicate device;
1. Utilizes the same number of wavelengths (i.e., 4 wavelengths between 605 nm 880 nm) as the predicate device;
1. Utilizes the same treatment duration (i.e., 180 seconds) as the predicate device;
1. Utilizes the same treatment regimen of five days a week for eight weeks.

The dpl® SpectraLite system and the above referenced predicate device are Over the Counter Devices used to treat wrinkles as defined in 21 CFR § 878.4810. These devices utilize red and IR diodes between 605 nm to 880 nm to provide narrow bands of light energy to treat wrinkles. The performance achieved by these devices is similar with equal power output. Based upon comparison to the predicate devices, the dpl® SpectraLite has the same intended uses, with similar technological characteristics as the predicate device.

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The devices are intended to be placed directly on the skin. The materials used for the device are similar to what is used in the dpl® Nüve, with the addition of the TPE Silicone for user comfort. No new biocompatibility issues are introduced with the addition of TPE Silicone.

The dpl® SpectraLite is battery powered (Ll-Ion Battery 5V USB & 3.7 V Battery). Battery is charged via Universal USB charger cord. The change in energy (the addition of battery) is usually part of a redesign to provide a portable version of a predicate device. The indication for use does not change and is not expanded. Operation of device does not change. The system performs as intended and does not raise any new safety or effectiveness issues.

6. Performance Testing and Standards:

Testing of the dpl® SpectraLite system, included functional performance testing, software validation testing, and user safety testing.

Safety and functionality testing demonstrates that the dpl® Spectralite system conforms to various international consensus standards.

IEC 60601-1: (2012) Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance.

IEC 62471: (2006): Photobiological safety of lamps and lamp systems.

IEC 60601-1-2 (2014): Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Compatibility.

Additional Tests for CE Medical Certification

IEC 61000-3-2: (2014): Electromagnetic Compatibility (EMC) – Part 3-2: Limits – Limits for Harmonic Current Emissions (Equipment Input Current ≤ 16 A Per Phase).

IEC 61000-3-3: (2013): Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16 A per phase and not subject to conditional connection.

EC 1907/2006 - Registration, Evaluation, Authorization and Restriction of Chemicals – REACH

IEC 62321:2008 Ed. 1.0 - Electrotechnical products - Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated dipheny) ethers).

IEC 62321 -4: 2013 - Determination of certain substances in electrotechnical products - Part 4: Mercuryin polymers, metals and electronics by CV-AAS, CV-AFS, ICP-OES and ICP-MS.

IEC 62321 -5:2013 - Determination of certain substances in electrotechnical products - Part 5: Cadmium, lead and chromium in polymers and electronics and cadmium and lead in metals by AAS, AFS, ICP-OES and ICP-MS.

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IEC 62321-6:2015 - Determination of certain substances in electrotechnical products - Part 6: Polybrominated biphenyls and polybrominated diphenyl ethers in polymers by gas chromatography mass spectrometry (GC-MS).

IEC 62321-8 CVD – Determination of certain substances in electrotechnical products – Part 8: Phthalates in polymers by gas chromatography-mass spectrometry (GC-MS), gas chromatography-mass spectrometry using a pyrolizer/thermal desorption accessory (Py-TD-GC-MS).

UN 38.3 Battery Certification.

Additional FCC Testing Performed for Retail Request

FCC 47 CFR Part 15 Subpart B - Radio frequency devices.

Biocompatibility

US FDA 21 CFR 177.1810: Styrene block polymers – TPE Test

The dpl® SpectraLite system software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices".

A Usability Study was conducted with 15 participants.

The results of the study found that:

100% of the participants were able to demonstrate the light sensitivity test.

100% of the participants were able to use the device successfully.

The conclusions drawn from nonclinical tests demonstrate that the device is safe, as effective, and performs as well as the legally marketed devices.

7. Statement of Safety Effectiveness:

The information in this 510 (k) submission was used to support the safety and effectiveness of this device with respect to its cited properties.

8. Summary

After analysis of safety, indications, intended uses, dose rates, performance, features, design materials, power output, technological properties, treatment regimens and methods of operation, the manufacturer asserts that no significant differences exist between the subject device and predicate, and no different questions of safety and effectiveness arise. Therefore, the subject device is substantial equivalence to the predicate.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.