(104 days)
No
The device description and performance studies focus on LED technology and user interaction, with no mention of AI or ML algorithms, data processing, or training/test sets.
Yes
The device is described as an LED device intended for use in treating mild to moderate inflammatory acne, which is a therapeutic purpose.
No
The device is described as an "LED device intended for use in treating mild to moderate inflammatory acne," which indicates a therapeutic purpose rather than a diagnostic one. It does not mention any function for identifying or analyzing a condition.
No
The device description explicitly states that the system includes a unit containing an LED module, a USB power cord, and a power adapter, indicating it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The reVive Light Therapy® LED Cleansing System is a light therapy device that is applied directly to the skin to treat acne. It does not analyze any samples taken from the body.
- Intended Use: The intended use is for treating mild to moderate inflammatory acne, which is a direct therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and the light wavelengths emitted, not on any methods for analyzing biological samples.
Therefore, the device's function and intended use clearly place it outside the category of In Vitro Diagnostics.
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 mild to moderate inflammatory acne.
Product codes (comma separated list FDA assigned to the subject device)
OLP
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 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 reVive Light Therapy® LED Cleansing System components include the unit containing the LED module, USB power cord, and power adapter. 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
It is intended for users 13 years or older.
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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 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.
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.
The self-selection study was not conducted, as the box labeling was comparable to that of primary predicate.
The performance testing was conducted measuring the temperature during the common use of the device. The test results demonstrated that the temperature of the device does not exceed 41C, even after the continuous use for 30 minutes, 10 times longer than the recommended treatment time of 3 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K081307, K170260, K132383, K160691
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.
0
Image /page/0/Picture/0 description: The image contains 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.
June 4, 2018
LED Technologies, Inc. Jelena Barbaric Compliance Manager 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village, Colorado 80111
Re: K180447
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: OLP 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, 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 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
Page 2 - Jelena Barbaric
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,
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) K180447
Device Name reVive Light Therapy® LED Cleansing System
Indications for Use (Describe)
mative Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating 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)
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:
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3
510 (k) Summary
This summary of 510 (k) information is being submitted in accordance with the requirements of 21 CFR § 807.92.
Preparation Date: June 1st, 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: 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 OLP
- 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 mild to moderate inflammatory acne. The device uses two types of LEDs: 630nm red and 415nm
4
blue. The treatment time is controlled by the user. There are no user settings or adjustments required.
The reVive Light Therapy® LED Cleansing System components include the unit containing the LED module, USB power cord, and power adapter.
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). It is intended for users 13 years or older.
4. Indications/Intended Use:
The reVive Light Therapy® LED Cleansing System 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 predicates, which are currently in safe and effective commerce under product codes OLP:
Primary predicate:
K153081 – Clear Bi-Light (Michael Todd)
Reference predicates: K081307 – OmniLux Clear U K170260 – BC-001 + Acne Purifier K132383 – Nutra Light Blue K160691 – Acne Light Therapy Wand
| Device | reVive Light
Therapy® LED
Cleansing
System
K180447 | Clear Bi-Light
K153081 | OmniLux
Clear U
K081307 | BC-001 +
Acne Purifier
K170260 | Nutra Light
Blue
K132383 | Acne Light
Therapy Want
K160691 |
|----------------------|----------------------------------------------------------------|-------------------------------|--------------------------------|--------------------------------------|--------------------------------|---------------------------------------|
| Wavelengths | 415nm,
630nm | 405-420nm
630-660nm | 415nm,
633nm | 415nm
660nm | 410nm | 442nm
630nm |
| Irradiance
source | LED | LED | LED | LED | LED | LED |
| Treatment
Area | 18.86 cm² | 20 cm² | 28.7 cm² | 9.1 | 31.6 | 1.594 |
| Treatment
Time | 3 minutes per
treatment | 3 minutes
per
treatment | 20 minutes
per
treatment | 1.5 minutes
per area | 3 minutes
treatment | 3 minutes per
treatment |
5
| Type/Class | OTC | OTC | OTC | OTC | OTC | OTC |
|---|---|---|---|---|---|---|
| ﺭﺍ ﺍﻟﮑﺎ | رال الا | رال الا | ﺭ ﺍﻟﺤﺎ | رال الا | UIL | |
Predicate Chart
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 devices;
-
- Utilizes the same/similar treatment duration as the predicate devices;
-
- 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 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 devices, the reVive Light Therapy® LED Cleansing System 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 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: (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,
Biocompatibility
ISO 10993-5:2009 – Cytotoxicity Test ISO 10993-10:2010 – Intracutaneous reactivity test ISO 10993-10:2010 – Skin Sensitization Test
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".
6
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.
Self-Selection Study
The self-selection study was not conducted, as the box labeling was comparable to that of primary predicate.
Thermal Performance Testing
The performance testing was conducted measuring the temperature during the common use of the device. The test results demonstrated that the temperature of the device does not exceed 41C, even after the continuous use for 30 minutes, 10 times longer than the recommended treatment time of 3 minutes.
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.