(84 days)
Not Found
No
The description focuses on LED light therapy and a cleansing function, with no mention of AI or ML capabilities, data processing, or algorithms.
Yes
The device is intended for "treating wrinkles," which is a therapeutic purpose.
No
The device is intended for treating wrinkles, not for diagnosing conditions.
No
The device description explicitly states it is an "over-the counter light emitting diode (LED) device" and lists hardware components such as the device containing the LED module, USB power cord, and power adapter.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The reVive Light Therapy® LED Cleansing System is a light therapy device applied directly to the skin for the treatment of wrinkles. It also has a cleansing function. It does not analyze any biological samples.
- Intended Use: The intended use is for treating wrinkles, which is a therapeutic application, not a diagnostic one.
The information provided clearly describes a device that interacts with the body externally for therapeutic and cosmetic purposes, not for analyzing biological samples in vitro.
N/A
Intended Use / Indications for Use
The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating wrinkles.
Product codes
OHS
Device Description
The reVive Light Therapy® LED Cleansing 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 types of LEDs: 605nm amber, 630nm red, and 880nm infrared. In addition to the LED light therapy treatment function, reVive Light Therapy® LED Cleansing System has a separate function for cleansing. The system includes two cleansing brush-heads, constructed of TPE material.
The reVive Light Therapy® LED Cleansing System 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. 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
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
Testing of the reVive Light Therapy® LED Cleansing System, included functional performance testing, software validation, testing, and user safety testing.
Safety and functionality testing demonstrates that the reVive Light Therapy® LED Cleansing 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 60601-1-2 (2014): Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Compatibility.
Biocompatibility testing was conducted on the ABS material used in the device construction and also on the TPE material of the brush head.
ISO 10993-5:2009 – Cytotoxicity Test: The test article extract did not show potential toxicity to test cell culture.
ISO 10993-10:2010 – Intracutaneous reactivity test: The test result showed that the applied sample extract did not induce intracutaneous reactivity in the test subject under the test conditions.
ISO 10993-10:2010 – Skin Sensitization Test: The test article extract showed no significant evidence of causing skin sensitization in the test subjects under the conditions of the study.
The reVive Light Therapy® LED Cleansing 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.
Key Metrics
Not Found
Predicate Device(s)
K171390, K141181, K162489, K152332
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/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.
May 15, 2018
LED Technologies, Inc. Jelena Barbaric Compliance Manager 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village, Colorado 80111
Re: K180445
Trade/Device Name: reVive Light Therapy LED Cleansing System 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: February 16, 2018 Received: February 20, 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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. 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
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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) K180445
Device Name reVive Light Therapy® LED Cleansing System
Indications for Use (Describe) marcanolis of the rapy® LED Cleansing System is an Over-the-Counter (OTC) LED 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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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: February 16th, 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: Light Based Over-The-Counter Wrinkle Reduction
- 2.2 Common/usual name: reVive Light Therapy® LED Cleansing System
- 2.3 Proprietary Names: reVive Light Therapy® LED Cleansing System
- 2.4 Classification: Class II
- 2.5 Classification Number: 878.4810
- 2.6 Product Code: OHS
- 2.7 Review Panel: General & Plastic Surgery
3. Device Description
The reVive Light Therapy® LED Cleansing 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 types of LEDs: 605nm amber, 630nm red, and 880nm infrared.
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In addition to the LED light therapy treatment function, reVive Light Therapy® LED Cleansing System has a separate function for cleansing. The system includes two cleansing brush-heads, constructed of TPE material.
The reVive Light Therapy® LED Cleansing System 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. The device is sold as Over the Counter (OTC).
4. Indications/Intended Use:
The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating wrinkles.
5. Predicate Device:
This device is substantially equivalent to the following predicates, which are currently in safe and effective commerce under product codes OHS:
K171390 – dpl® II Panel (LED Technologies, Inc.) K141181 - dpl® Nüve wrinkle (LED Technologiees, Inc.) K162489 – Red Light Device K152332 - Perfectio LED Infrared Device
Predicate Chart
| Device | reVive Light
Therapy®
LED
Cleansing
System
K180445 | dpl® II Panel
LED
Technologies,
Inc.
K171390 | dpl® Nüve
wrinkle
LED
Technologies,
Inc.
K141181 | Red Light
Device
K162489 | Perfectio LED
Infrared
Device
K152332 |
|----------------------|-------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------|--------------------------------|------------------------------------------------|
| Wavelengths | 605nm,
630nm,
660nm,
880nm | 605nm,
630nm,
660nm,
880nm | 605nm,
630nm,
660nm, 880nm | 633nm
830nm | 633nm
830nm |
| Irradiance
source | LED | LED | LED | LED | LED |
| Treatment
Area | 18.86 cm² | 415 cm² | 27 cm² | 17 cm² | 17 cm² |
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| Treatment
Time | 3 minutes
per
treatment | 3 minutes per
treatment | 3 minutes per
treatment | 5-7 minutes
per treatment
area | 5-7 minutes
per treatment
area |
|-------------------|---------------------------------|------------------------------|------------------------------|---------------------------------------------|---------------------------------------------|
| Type/Class | OTC | OTC | OTC | OTC | OTC |
| IFU | For
treatment of
wrinkles | For treatment
of wrinkles | For treatment
of wrinkles | For treatment
of periorbital
wrinkles | 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 device (l.e., treatment of wrinkles);
-
- Has the similar output (mW/cm2) as predicate devices;
-
- Utilizes the same/similar treatment duration) as the predicate device;
-
- Utilizes the similar recommended treatment regimen.
The reVive Light Therapy® LED Cleansing system and the above referenced predicate devices 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 same/similar 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 devices, the reVive Light Therapy® LED Cleansing System has the same/similar 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 reVive Light Therapy® LED Cleansing System, included functional performance testing, software validation, testing, and user safety testing.
Safety and functionality testing demonstrates that the reVive Light Therapy® LED Cleansing 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 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
The material that comes in contact with patient's skin during use of reVive Light Therapy® LED Cleansing system is the ABS material, the identical material as used in construction of predicate devices dpl® Nüve and dpl® II Panel.
The biocompatibility testing was conducted on the dpl® Nüve handle that is constructed of ABS material, which demonstrates the safety of the ABS material used in construction of dpl® Nüve and equivalently in the construction of the reVive Light Therapy® LED Cleansing system.
In addition, the brush head will also come into contact with patient skin. The brush head is constructed form TPE material. The biocompatibility testing was conducted for TPE material and provided as a part of biocompatibility report.
ISO 10993-5:2009 – Cytotoxicity Test
Purpose of the Test:
The purpose of the test is to determine the biological reactivity of a test cell culture in response to the test article.
Test Summary:
Under the conditions of the study, the test article extract did not show potential toxicity to test cell culture.
ISO 10993-10:2010 – Intracutaneous reactivity test
Purpose of the Test:
The test was designed to determine the potential intracutaneous reactivity caused by the extract.
Test Summary:
The test result showed that the applied sample extract did not induce intracutaneous reactivity in the test subject under the test conditions.
ISO 10993-10:2010 – Skin Sensitization Test
Purpose of the Test:
The test was designed to evaluate the potential of a test article to cause skin sensitization.
Test Summary:
According to the results, the test article extract showed no significant evidence of causing skin sensitization in the test subjects under the conditions of the study.
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The reVive Light Therapy® LED Cleansing 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.
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. 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 subject device and predicate, and no different questions of safety and effectiveness arise. Therefore, the subject device is substantial equivalence to the predicate.