(259 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 no user settings or complex processing.
Yes.
The device is intended for the treatment of wrinkles, which is a therapeutic purpose.
No
The device is intended for the treatment of wrinkles and not for the diagnosis of any condition.
No
The device description explicitly states it is an "over-the counter light emitting diode (LED) device" and lists hardware components like the "device containing the LED module." It also mentions "functional performance testing" and "user safety testing" which are typical for hardware devices. While software validation is mentioned, it's in the context of a hardware device.
Based on the provided information, the reVive Light Therapy® Essentials is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "treatment of wrinkles" by applying light directly to the skin. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is an LED light therapy device that emits energy for dermatological treatment. It does not involve testing samples of human origin (like blood, urine, or tissue) to provide information about a physiological state, health, or disease.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample handling, or analysis of biological samples.
IVD devices are used to perform tests in vitro (outside the body) on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. The reVive Light Therapy® Essentials operates in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The reVive Light Therapy® Essentials is an Over the Counter (OTC) device intended for treatment of writkles.
The reVive Light Therapy® Essentials is an Over the Counter (OTC) LED device intended for use in treating wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
OHS
Device Description
The reVive Light Therapy® Essentials 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, 660nm red, and 880nm infrared.
The reVive Light Therapy® Essentials components include the device containing the LED module.
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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the reVive Light Therapy® Essentials, included functional performance testing, software validation, testing, and user safety testing.
Safety and functionality testing demonstrate that the reVive Light Therapy® Essentials conforms to various international consensus standards.
ANSI/AAMI ES 60601-1:2005® + 2012 and A1:2012 IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012: Medical Electrical Equipment part 1: General Requirements for Basic Safety and Essential Performance.
ANSI/AAMI/IEC 60601-1-2 (2014): 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® Essentials 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 17 participants.
The results of the study found that:
100% of the participants were able to demonstrate the correct preparation of device for use.
100% of the participants were able to demonstrate correct device usage.
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): 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.
0
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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
December 15, 2021
LED Technologies, Inc. Jelena Barbaric Compliance Manager 12821 Starkey Rd., Suite 4900 Largo, Florida 33773
Re: K210965
Trade/Device Name: reVive Light Therapy Essentials 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: March 29, 2021 Received: March 31, 2021
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210965
Device Name reVive Light Therapy® Essentials
Indications for Use (Describe)
The reVive Light Therapy® Essentials is an Over the Counter (OTC) device intended for treatment of writkles.
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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3
510(k) Summary - K210965
This summary of 510 (k) information is being submitted in accordance with the requirements of 21 CFR § 807.92.
Submission Date: December 14th, 2021
| 1. Submitter Information: | LED Technologies, Inc. - Jelena Barbaric |
|---|---|
| 12821 Starkey Rd., Suite 4900 | |
| Largo, FL 33773 | |
| Tel: 727-285-8300 Ext 203 | |
| Email: jbarbaric@ledtechnologies.com |
For Specification Developer: LED Technologies, Inc. Attn: Lloyd Nelson 12821 Starkey Rd., Suite 4900 Largo, FL 33773 Tel.: 727-285-8300. Ext 201 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® Essentials
- 2.3 Proprietary Names: reVive Light Therapy® Essentials
- Classification: Class II 2.4
- Classification Number: 878.4810 2.5
- 2.6 Product Code: OHS
- 2.7 Review Panel: General & Plastic Surgery
3. Device Description
The reVive Light Therapy® Essentials 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, 660nm red, and 880nm infrared.
4
The reVive Light Therapy® Essentials components include the device containing the LED module.
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 reVive Light Therapy® Essentials is an Over the Counter (OTC) LED device intended for use in treating wrinkles.
Predicate Devices: 4.
K171390 – dpl® II Panel (LED Technologies, Inc.) K180445 – reVive Light Therapy® LED Cleansing System (LED Technologies, Inc.)
Comparison Chart
| Device | reVive Light
Therapy® Essentials
K210965 | dpl® II Panel
LED Technologies,
Inc.
K171390 | reVive Light Therapy® LED
Cleansing System
LED Technologies, Inc.
K180445 |
|-------------------------|------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------|
| Wavelengths | 605nm, 630nm,
660nm, 880nm | 605nm, 630nm,
660nm, 880nm | 605nm, 630nm,
660nm, 880nm |
| Irradiance
source | LED | LED | LED |
| Treatment Area
(cm²) | 7 | 415 | 18.86 |
| Treatment Time | 3 minutes per
treatment | 3 minutes per
treatment | 3 minutes per treatment |
| Type/Class | OTC | OTC | OTC |
| IFU | For treatment of
wrinkles | For treatment of
wrinkles | For treatment of wrinkles |
5
5. Summary of the technological characteristics of the device compared to predicate device:
-
- Has the same intended use as the predicate devices (i.e., treatment of wrinkles).
-
- Has the similar technical characteristics.
-
- Has the same method of operation.
-
- Utilizes the same treatment duration as the predicate devices.
The reVive Light Therapy® Essentials 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 with similar power output.
The reVive Light Therapy® Essentials is powered by Batteries) or via Universal USB power source.
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® Essentials 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.
6. Performance Testing and Standards:
Testing of the reVive Light Therapy® Essentials, included functional performance testing, software validation, testing, and user safety testing.
Safety and functionality testing demonstrate that the reVive Light Therapy® Essentials conforms to various international consensus standards.
ANSI/AAMI ES 60601-1:2005® + 2012 and A1:2012 IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012: Medical Electrical Equipment part 1: General Requirements for Basic Safety and Essential Performance.
ANSI/AAMI/IEC 60601-1-2 (2014): 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
6
The reVive Light Therapy® Essentials 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 17 participants.
The results of the study found that:
100% of the participants were able to demonstrate the correct preparation of device for use.
100% of the participants were able to demonstrate correct device usage.
The conclusions drawn from nonclinical tests demonstrate that the device is safe, as effective, and performs as well as the legally marketed devices.
7. 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.