(88 days)
Not Found
No
The device description and performance studies do not mention any AI or ML components or capabilities. The device is a simple LED light therapy device with user-controlled treatment time.
Yes
Explanation: The device is intended for "treating wrinkles," which is a therapeutic purpose.
No
The device is described as treating wrinkles, not diagnosing any condition. Its intended use and description focus on emitting light for therapeutic purposes.
No
The device description explicitly states it is an "over-the counter light emitting diode (LED) device" and lists physical components like the LED module, USB charging cord, and storage case. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating wrinkles within the periorbital region. This is a therapeutic use applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an LED light therapy device that emits energy for dermatological treatment. It does not involve analyzing biological samples.
- 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 samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a therapeutic device used to treat a cosmetic condition directly on the skin.
N/A
Intended Use / Indications for Use
The dpl® SpectraLite is an Over-the-Counter (OTC) device intended for use in treating wrinkles within periorbital region.
Product codes
OHS
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter (OTC) device
layman
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)
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.)
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.
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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 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
1
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
2
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
4
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® SpectraLite
LED Technologies, Inc.
KXXXXXXXX
This Submission | dpl® Nüve for Wrinkles
LED Technologies, Inc.
K141181
A Predicate Device |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Indications | The dpl® SpectraLite is an
Over-the-Counter (OTC)
device intended for the use
in treating wrinkles within
periorbital region. | The dpl® Nüve for Wrinkles is
an Over-the-Counter (OTC)
device intended for the use
in 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 Power | |
| Adapter | 120-240V AC Power Adapter | |
| Treatment Time | 3 minutes per treatment | 3 minutes per treatment |
| Target Population | Individuals with wrinkles on | |
| their face within the | ||
| periorbital region. | Individuals with wrinkles on | |
| their face. | ||
| 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 (I.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® 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.
7
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.