(84 days)
Not Found
No
The device description and performance studies focus on LED technology and user usability, with no mention of AI or ML capabilities.
YES
The device is intended for "treating wrinkles," which is a therapeutic purpose.
No
The device is intended for the treatment of wrinkles using LED light, not for diagnosing any medical condition.
No
The device description explicitly lists hardware components such as the panel unit containing the LED module, power supply, goggles, and storage case, indicating it is a hardware device with embedded software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in treating wrinkles." This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an LED light therapy device applied directly to the skin. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological specimens (like blood, urine, tissue, etc.), which are fundamental to IVDs.
Therefore, the dpl® II Panel system is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The dpl® II Panel system is an Over-the Counter (OTC) device intended for use in treating wrinkles.
Product codes
OHS
Device Description
The dpl® II Panel system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles. The device uses four type of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required.
The dpl® II Panel system components include the panel unit containing the LED module, power supply, goggles, and 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).
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
Over-The-Counter Use
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
The dpl® II Panel 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 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/2 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2017
LED Technologies, Inc. Jelena Barbaric Compliance Manager 6000 Greenwood Plaza Blvd.. Suite 110 Greenwood Village, Colorado 80111
Re: K171390
Trade/Device Name: dpl II Panel 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 8, 2017 Received: May 11, 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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Sincerelv. Jennifer R. Stevenson -23
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)
K171390
Device Name dpl® II Panel
Indications for Use (Describe)
The dpl® II Panel system is an Over-the Counter (OTC) device intended for use in treating wrinkles.
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
This summary of 510 (k) information is being submitted in accordance with the requirements of 21 CFR § 878.4810.
Submission Date: May 8th, 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 | ||
| Tel.: 303-407-6884 | ||
| Email: lnelson@ledtechnologies.com |
2. General Information
- 2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction device
- 2.2 Common/usual name: dpl® II Panel
- 2.3 Proprietary Names: dpl® II Panel
- 2.4 Classification: Class II
- 2.5 Classification Number: 878.4810
- 2.6 Product Code OHS
- 2.7 Regulation Medical Specialty: General & Plastic Surgery
- Office of Device Evaluation (ODE) 2.8 Review Panel: Division of Surgical Devices (DSD) General Surgery Device Branch One - Light Based/Laser (GSDB1)
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3. Device Description
The dpl® II Panel system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles. The device uses four type of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required.
The dpl® II Panel system components include the panel unit containing the LED module, power supply, goggles, and 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® II Panel is an Over-the-Counter (OTC) device intended for use in treating wrinkles.
Rx or OTC:
The dpl® II Panel 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® II Panel
LED Technologies, Inc.
KXXXXXXXX
This Submission | dpl® Nüve for Wrinkles
LED Technologies, Inc.
K141181
A Predicate Device |
|-------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Indications | The dpl® II Panel is an Over-
the-Counter (OTC) device
intended for the use in
treating wrinkles. | The dpl® Nüve for Wrinkles is
an Over-the-Counter (OTC)
device intended for the use
in treating wrinkles. |
| Wavelengths | 605 nm, 630 nm, 660 nm,
880 nm | 605 nm, 630 nm, 660 nm,
880 nm |
Predicate Chart
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| Modes | On/Off | On/Off |
|---|---|---|
| Irradiance Source | LED | LED |
| Visible light LEDs | Yes | Yes |
| Treatment Area | $415 cm^2$ | $30 cm^2$ |
| Energy Level | $70.16 mW/cm^2$ | $62.07 mW/cm^2$ |
| Power Supply | 120-240V AC Power Adapter | 120-240V AC Power Adapter |
| Treatment Time | 3 minutes per treatment | 3 minutes per treatment |
| Target Population | Individuals with wrinkles. | Individuals with wrinkles. |
| Location for Use | OTC | OTC |
Summary of the technological characteristics of the device compared to predicate device:
-
- Has the same intended use as the predicate device (l.e., treatment of wrinkles);
-
- Has the same/similar output (i.e., 62 mW/cm2) as the predicate device;
-
- Utilizes the same number of wavelengths (i.e., 4 wavelengths between 605 nm 880 nm) as the predicate device;
-
- Utilizes the same treatment duration (i.e., 180 seconds) as the predicate device;
-
- Utilizes the same treatment regimen of five days a week for eight weeks.
The dpl® II Panel 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. The devices are intended to be placed directly on the skin. They are manufactured out of similar materials. Based upon comparison to the predicate devices, the dpl® II Panel system has the same
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intended uses, with similar technological characteristics as the predicate device. The system performs as intended and does not raise any new safety or effectiveness issues.
6. Performance Testing and Standards:
Testing of the dpl® II Panel system, included functional performance testing, software validation, testing, and user safety testing.
Safety and functionality testing demonstrates that the dpl® II Panel conforms to various international consensus standards.
IEC 60601-1: (2006): medical Electrical Equipment part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-2 (2007): Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Compatibility.
ISO 10993-10:2010 Biological evaluation of medical devices part 10: Tests for irritation and delayed-type hypersensitivity.
The dpl® II Panel 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 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.
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. Substantial Equivalence Discussion
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 applicant device and predicate listed in the predicate chart, and no new issues arise for safety and effectiveness. Therefore, substantial equivalence is hereby requested.