The dpl® SpotLite is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs, 630nm red and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The dpl® SpotLite components include the unit containing the LED module. 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

Here's an analysis of the provided text regarding the acceptance criteria and study information for the dpl® SpotLite device:

Based on the provided text, the submission focuses on substantial equivalence to a predicate device rather than demonstrating the device meets pre-defined acceptance criteria through a specific clinical study for efficacy. The performance testing mentioned is primarily for safety, functional performance, software validation, and usability, not clinical effectiveness.

Therefore, the requested information elements (especially those related to clinical effectiveness studies, sample sizes for test/training sets, expert ground truth, adjudication, and MRMC studies) are largely not present in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Safety:
IEC 60601-1 (Basic Safety & Essential Performance)	Conforms to standard.
IEC 60601-1-2 (EMC)	Conforms to standard.
ISO 10993-5 (Cytotoxicity Test)	Conforms to standard.
ISO 10993-10 (Intracutaneous reactivity test)	Conforms to standard.
ISO 10993-10 (Skin Sensitization Test)	Conforms to standard.
Functionality:
Functional Performance Testing	Performed.
Software Validation	Tested and validated (Guidence for the content of Premarket Submissions for Software Contained in Medical Devices).
Usability:
Ability to demonstrate light sensitivity test	100% of participants successful.
Ability to use the device successfully	100% of participants successful.
Substantial Equivalence to Predicate:
Same intended use	Yes (treatment of mild to moderate inflammatory acne).
Similar output (mW/cm²)	Yes.
Same treatment duration	Yes (3 minutes per treatment).
Similar recommended treatment regimen	Yes.
Similar technological characteristics	Yes (red and blue diodes at 630 and 415 nm, similar power output, direct skin placement, similar materials).
No new safety or effectiveness issues raised	Stated that no new issues arise.

2. Sample size used for the test set and the data provenance

Test Set Sample Size (for clinical effectiveness/efficacy): Not applicable. The document does not describe a clinical effectiveness study with a test set for efficacy.
Test Set Sample Size (for usability study): 16 participants.
Data Provenance: Not specified for the usability study (e.g., country of origin). The study is described as a "Usability Study," implying it was prospective for that purpose.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No experts were used to establish ground truth for a clinical effectiveness test set because such a study is not described. The usability study's "ground truth" would be the successful completion of tasks by the participants itself, not an expert panel reviewing outcomes.

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

Not applicable. No clinical effectiveness test set or complex judgment of outcomes requiring adjudication is described.

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

Not applicable. This device is an LED therapy device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or described.

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

Not applicable. This device is a direct-treatment device, not an algorithm.

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

For safety and functional testing: Ground truth is conformity to established international consensus standards (IEC, ISO).
For software validation: Ground truth is adherence to FDA guidance for software in medical devices.
For usability study: Ground truth is the direct observation of participants' ability to successfully perform specified tasks (demonstrating light sensitivity test, using the device successfully).

8. The sample size for the training set

Not applicable. No clinical effectiveness study is described, and thus no training set for an algorithm is mentioned.

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

Not applicable. As no training set is discussed, the method for establishing its ground truth is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to a previously cleared predicate device (reVive Light Therapy® LED Cleansing System K180447) rather than a de novo clinical study proving effectiveness against specific acceptance criteria.

The "study" component consists of:

Functional Performance Testing: Confirmed the device's operational capabilities. The details or results are not explicitly provided beyond stating that it was conducted.
Software Validation: Tested and validated in accordance with FDA guidance, ensuring its proper functioning.
User Safety Testing: Demonstrated conformity to various international consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10). These tests cover electrical safety, electromagnetic compatibility, cytotoxicity, intracutaneous reactivity, and skin sensitization.
Usability Study: Conducted with 16 participants. The study proved that 100% of participants could successfully demonstrate the light sensitivity test and use the device.

The overall conclusion is based on comparing the dpl® SpotLite's intended uses, technological characteristics (wavelengths, irradiance source, treatment time, class, output, treatment regimen, materials), and safety performance to the predicate device. The manufacturer asserts that the device is "as effective" and "performs as well as the legally marketed devices" because "no significant differences exist between the subject device and predicate, and no different questions of safety and effectiveness arise." This indicates that the primary "proof" of meeting efficacy criteria is through the established safety and efficacy of the predicate, to which the dpl® SpotLite is deemed substantially equivalent.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

February 7, 2019

Re: K183118

Trade/Device Name: dpl SpotLite 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: OLP Dated: November 7, 2018 Received: November 9, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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).

Sincerely,

Neil R
Ogden -S
Digitally signed by Neil R
Ogden -S
Date: 2019.02.07
09:57:41 -05'00'

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

510(k) Number (if known)

K183118

Device Name dpl® SpotLite

Indications for Use (Describe)

The dol@ SpotLite is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

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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Prior Submissions

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Prior Submissions

ﻳﺮ ﺳﺎﻧﺘﻬﺎﺭ ﻓﻲ ﻣﻦ ﺍﻟﻘﺎﻧﻮﻥ ﺍﻟﻤﻠﻜﺔ ﺍﻟﻤﺘﻮﻯ

参考文献

10-1

There are not prior submissions for this device.

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K183118

510 (k) Summary

This summary of 510 (k) information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Submission Date: February 6th, 2018

1. Submitter Information:	LED Technologies, Inc. – Jelena Barbaric6000 Greenwood Plaza Blvd., Suite 110Greenwood Village, CO 80111Tel: 303-407-6882Email: jbarbaric@ledtechnologies.com
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For Specification Developer: LED Technologies, Inc.

Attn: Lloyd Nelson

6000 Greenwood Plaza Blvd., Suite 110

Greenwood Village, CO, 80111

Tel.: 303-646-0543. Ext 117

Email: Inelson@ledtechnologies.com

2. General Information

2.1 Classification Name: Over-The- Counter Light Based Laser for Acne
2.2 Common/usual device name: dpl® SpotLite
2.3 Proprietary Names: dpl® SpotLite
2.4 Classification: Class II
2.5 Classification Number: 878.4810
2.6 Product Code OLP
2.7 Review Panel: General & Plastic Surgery

3. Device Description

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The dpl® SpotLite components include the unit containing the LED module.

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).

4. Indications/Intended Use:

The dpl® SpotLite is an Over-the-Counter (OTC) device intended for use in treatment of mild to moderate inflammatory acne.

5. Predicate Device:

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

K180447 – reVive Light Therapy® LED Cleansing System

Predicate Chart

Device	dpl® SpotLiteKXXXXXX	reVive LightTherapy® LEDCleansing SystemK180447
Wavelengths	415nm, 630nm	415nm, 630nm
Irradiancesource	LED	LED
Treatment Time	3 minutes pertreatment	3 minutes pertreatment
Type/Class	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 mild to moderate inflammatory acne);
1. Has the similar output (mW/cm²) as predicate device;
1. Utilizes the same treatment duration as the predicate device;
1. Utilizes the similar recommended treatment regimen.

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The dpl® SpotLite and the above referenced predicate devices are Over the Counter Devices used to treat acne as defined in 21 CFR § 878.4810. These devices utilize red and blue diodes at 630 and 415 nm for treatment of mild to moderate inflammatory acne. The performance achieved by these devices is comparable with similar power output. The devices are intended to be placed directly on the skin. They are manufactured out of similar materials. Based upon comparison to the predicate device, the dpl® SpotLite has the same intended uses, with similar technological characteristics as predicate device. The system performs as intended and does not raise any new safety or effectiveness issues.

5. Performance Testing and Standards:

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

Safety and functionality testing demonstrate that the dpl® SpotLite conforms to various international consensus standards.

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

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

Biocompatibility

ISO 10993-5:2009 – Cytotoxicity Test ISO 10993-10:2010 – Intracutaneous reactivity test ISO 10993-10:2010 – Skin Sensitization Test

The dpl® SpotLite 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 16 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.

6. Conclusion

After analysis of safety, indications, intended uses, dose rates, performance, features, design materials, power output, technological properties, treatment regiment 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.