(90 days)
Not Found
No
The device description and performance studies focus on LED technology and standard safety/performance testing, with no mention of AI/ML algorithms or data training/testing.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for treatment of mild to moderate inflammatory acne." The "Device Description" also confirms it emits energy "for the treatment of mild to moderate inflammatory acne." Treatment implies a therapeutic purpose.
No
The device description clearly states its intended use is 'treatment of mild to moderate inflammatory acne' and it emits energy for this purpose. It does not mention any function for diagnosis or detection.
No
The device description explicitly states it is an "over-the counter light emitting diode (LED) device" and includes "the unit containing the LED module," indicating it is a hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of mild to moderate inflammatory acne." This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a light emitting diode (LED) device that emits energy for use in dermatology. It is applied directly to the skin. This describes a physical treatment device, not something that analyzes samples from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The dpl® SpotLite is a therapeutic device that uses light energy to treat a condition. IVDs are used to diagnose or provide information about a condition based on analysis of samples.
N/A
Intended Use / Indications for Use
The dol@ SpotLite is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Product codes
OLP
Device Description
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).
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
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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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3
Prior Submissions
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
4
Prior Submissions
ﻳﺮ ﺳﺎﻧﺘﻬﺎﺭ ﻓﻲ ﻣﻦ ﺍﻟﻘﺎﻧﻮﻥ ﺍﻟﻤﻠﻜﺔ ﺍﻟﻤﺘﻮﻯ
参考文献
10-1
There are not prior submissions for this device.
5
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 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
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
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.
6
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® SpotLite
KXXXXXX | reVive Light
Therapy® LED
Cleansing System
K180447 |
|----------------------|----------------------------|-------------------------------------------------------------|
| Wavelengths | 415nm, 630nm | 415nm, 630nm |
| Irradiance
source | LED | LED |
| Treatment Time | 3 minutes per
treatment | 3 minutes per
treatment |
| Type/Class | OTC | OTC |
Summary of the technological characteristics of the device compared to predicate device:
-
- Has the same intended use as the predicate device (I.e., treatment of mild to moderate inflammatory acne);
-
- Has the similar output (mW/cm²) as predicate device;
-
- Utilizes the same treatment duration as the predicate device;
-
- Utilizes the similar recommended treatment regimen.
7
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.