(113 days)
Not Found
No
The description focuses on the hardware (LEDs, power cord, adapter) and its function (emitting light for treatment). There is no mention of any software or algorithms that would suggest AI/ML capabilities. The device is described as having no user settings or adjustments, and the treatment time is user-controlled, further indicating a lack of complex internal processing.
Yes
The device is described as "intended for treatment of wrinkles and mild to moderate inflammatory acne," which directly implies a therapeutic purpose.
No
The device description and intended use clearly state that the dpl® Faceware is for "treatment of wrinkles and mild to moderate inflammatory acne" and emits energy for "use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne." It does not mention any diagnostic capabilities.
No
The device description explicitly states that the dpl® Faceware is an "over-the counter light emitting diode (LED) device" and lists physical components like the "device containing the LED module, USB power cord, and power adapter." This indicates 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The dpl® Faceware is a light-emitting device that applies light directly to the skin for therapeutic purposes (treating wrinkles and acne). It does not analyze any biological samples.
- Intended Use: The intended use clearly states "treatment of wrinkles and mild to moderate inflammatory acne," which is a therapeutic application, not a diagnostic one.
Therefore, based on the provided information, the dpl® Faceware is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The dpl® Faceware is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP
Device Description
The dpl® Faceware is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses five types of LEDs: 605nm amber, 630nm red, 880nm infrared, and 415 blue.
The dpl® Faceware components include the device containing the LED module, USB power cord, and power adapter.
The treatment time is controlled by the user. There are no user settings or adjustments required.
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.
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 (OTC)
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)
Testing of the dpl® Faceware, included functional performance testing, software validation, testing, and user safety testing.
Safety and functionality testing demonstrate that the dpl® Faceware conforms to various international consensus standards.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" in bold, followed by "ADMINISTRATION" in a smaller font size.
LED Technologies. Inc Jelena Barbaric Compliance Manager LED Technologies, Inc. 6000 Greenwood Plaza Blvd., Suite 110, Greenwood Village, CO 80111 US
March 14, 2019
Re: K183247
Trade/Device Name: dpl® Faceware 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, OLP Dated: February 15, 2019 Received: February 15, 2019
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 mediation-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).
Image /page/1/Figure/4 description: This image shows a digital signature and associated information. The signature is from Neil R Ogden -S, and the date of the signature is 2019.03.14 at 14:26:04 -04'00'. The document is addressed to Binita S. Ashar, M.D., M.B.A., F.A.C.S., who is the Director of the Division of Surgical Devices, Office of Device Evaluation, and Center for Devices and Radiological Health.
Enclosure
2
Indications for Use
510(k) Number (if known) K183247
Device Name dpl® Faceware
Indications for Use (Describe)
The dpl® Faceware is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | 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 § 807.92.
Submission Date: November 19th, 2018
-
- 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: Light Based Over-The-Counter Wrinkle Reduction/Over the Counter Light Based laser for Acne
- 2.2 Common/usual name: dpl® Faceware
- 2.3 Proprietary Names: dpl® Faceware
- 2.4 Classification: Class II
- 2.5 Classification Number: 878.4810
- 2.6 Product Code: OHS/OLP
- 2.7 Review Panel: General & Plastic Surgery
3. Device Description
The dpl® Faceware is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses five types of LEDs: 605nm amber, 630nm red, 880nm infrared, and 415 blue.
4
The dpl® Faceware components include the device containing the LED module, USB power cord, and power adapter.
The treatment time is controlled by the user. There are no user settings or adjustments required.
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.
Indications/Intended Use:
The dpl® Faceware is an Over-the-Counter (OTC) LED device intended for use in treating wrinkles and mild to moderate inflammatory acne.
4. Predicate Devices:
This device is substantially equivalent to the following predicates, which are currently in safe and effective commerce under product codes OHS/OLP:
K180320 - dpl® Ila Panel (LED Technologies, Inc.) K180447 - reVive Light Therapy® LED Cleansing System (LED Technologies, Inc.) K171386 - dpl® SpectraLite (LED Technologies, Inc.)
| Device | dpl® Faceware
KXXXXXXX | dpl® Ila Panel
LED Technologies,
Inc.
K180320 | reVive Light
Therapy® LED
Cleansing System
LED Technologies,
Inc.
K180447 | dpl® SpectraLite
LED Technologies,
Inc.
K171386 |
|-------------------------|-----------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Wavelengths | 605nm, 630nm,
660nm, 880nm,
415nm | 605nm, 630nm,
660nm, 880nm,
415nm | 630nm, 415nm | 605nm, 630nm,
660nm, 880nm |
| Irradiance
source | LED | LED | LED | LED |
| Treatment
Area (cm2) | 81 (acne)
135.8 (wrinkle) | 415 | 18.86 | 28 |
| Treatment
Time | 3 minutes per
treatment | 3 minutes per
treatment | 3 minutes per
treatment | 3 minutes per
treatment |
| Type/Class | OTC | OTC | OTC | OTC |
Comparison Chart
5
| IFU | For treatment of
wrinkles and mild to
moderate
inflammatory acne | For treatment of
wrinkles and mild to
moderate
inflammatory acne | For treatment of
mild to moderate
inflammatory acne | For treatment of
periorbital
wrinkles |
| ----- | --------------------------------------------------------------------------- | --------------------------------------------------------------------------- | ----------------------------------------------------------- | --------------------------------------------- |
|---|
Summary of the technological characteristics of the device compared to predicate device:
-
- Has the same/similar intended use as the predicate devices (I.e., treatment of wrinkles/mild to moderate inflammatory acne );
-
- Has the similar output (mW/cm2) as predicate devices;
-
- Utilizes the same/similar treatment duration as the predicate devices;
-
- Utilizes the similar recommended treatment regimen.
The dpl® Faceware and the above referenced predicate devices are Over the Counter Devices used to treat wrinkles and acne 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, and red and blue LED diodes to treat mild to moderate inflammatory acne. The performance achieved by these devices is same/similar with similar power output.
The dpl® Faceware is battery powered (LI-Ion Battery 5V USB & 3.7 V Battery is charged via Universal USB charger cord and is equivalent to the battery used in predicate device dpl® SpectraLite.
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® Faceware has the same intended uses, with similar technological characteristics as predicate devices. The system performs as intended and does not raise any new safety or effectiveness issues.
5. Performance Testing and Standards:
Testing of the dpl® Faceware, included functional performance testing, software validation, testing, and user safety testing.
Safety and functionality testing demonstrate that the dpl® Faceware 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.
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Biocompatibility
ISO 10993-5:2009 - Cytotoxicity Test ISO 10993-10:2010 - Intracutaneous reactivity test ISO 10993-10:2010 - Skin Sensitization Test
The dpl® Faceware 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.
6. 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.
7. Conclusion
After analysis of safety, indications, intended uses, dose rates, performance, features, design materials, power output, technological properties, treatment areas, 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.