(126 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components or functionalities. The device is a simple LED light therapy system with user-controlled treatment time and no user settings.
Yes
The device is intended for the "treatment of fine lines and wrinkles, and increase in circulation within the perioral region," which are therapeutic applications.
No
The device is intended for treatment of fine lines and wrinkles and increasing circulation, not for diagnosing medical conditions.
No
The device description explicitly states it is an "over-the counter light emitting diode (LED) device" and lists physical components like the device containing the LED module, USB charging cord, and a storage bag. This indicates it is a hardware device with embedded technology, not a software-only device.
Based on the provided information, 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 reVive® Perioral LED Light Therapy system is a light-emitting device applied directly to the skin for therapeutic purposes (treating fine lines and wrinkles, increasing circulation). It does not analyze any biological samples.
- Intended Use: The intended use clearly states treatment of fine lines and wrinkles and increasing circulation, which are therapeutic applications, not diagnostic ones.
Therefore, the reVive® Perioral LED Light Therapy system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The reVive® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.
Product codes (comma separated list FDA assigned to the subject device)
OHS, ILY
Device Description
The reVive® Perioral LED Light Therapy system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for treatment fine lines and wrinkles, and increase in circulation within the perioral region. The device uses four types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required.
The reVive® Perioral LED Light Therapy system components include the device containing the LED module, USB charging cord, and a storage bag.
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
perioral region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter (OTC) device
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)
Performance Testing and Standards:
Testing of the reVive® Perioral LED Light Therapy system, included functional performance testing, and software validation testing.
Safety and functionality testing demonstrates that the reVive® Perioral LED Light Therapy 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.
UL 1642 Battery Certification UN 38.3 Battery Certification.
Biocompatibility
ISO 10993-5:2009 – Cytotoxicity Test ISO 10993-10:2010 – Intracutaneous reactivity test ISO 10993-10:2010 – Skin Sensitization Test
The reVive® Perioral LED Light Therapy 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 (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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 9, 2018
LED Technologies, Inc. Ms. Jelena Barbaric Compliance Manager 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village, Colorado 80111
Re: K172662
Trade/Device Name: reVive Perioral LED Light Therapy 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. ILY Dated: October 12, 2017 Received: October 12, 2017
Dear Ms. 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
Page 2 - Ms. 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 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
2
Indications for Use
510(k) Number (if known) K172662
Device Name
The reVive® Perioral LED Light Therapy system
Indications for Use (Describe)
Indications for Use (Describe)
The reVive® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral 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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3
510 (k) Summary
This summary of 510 (k) information is being submitted in accordance with the requirements of 21 CFR § 878.4810.
Submission Date: August 31st, 2017
Preparation Date: January 9th, 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 11 | |
| Greenwood Village, CO, 80111 | |
| Tel.: 303-407-6884 | |
| Email: Inelson@ledtechnologies.com |
2. General Information
- 2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction device
- 2.2 Common/usual name: reVive® Perioral LED Light Therapy system
- 2.3 Proprietary Names: reVive® Perioral LED Light Therapy system
- 2.4 Classification: Class II
- 2.5 Classification Number: 878.4810
- 2.6 Product Code OHS, ILY
- 2.7 Review panel: General & Plastic Surgery
4
3. Device Description
The reVive® Perioral LED Light Therapy system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for treatment fine lines and wrinkles, and increase in circulation within the perioral region. The device uses four types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required.
The reVive® Perioral LED Light Therapy system components include the device containing the LED module, USB charging cord, and a storage bag.
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® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.
5. Predicate Devices:
This device is substantially equivalent to the following predicate, which is currently legally marketed under product code OHS:
- K141181 dpl® Nuve for wrinkles (LED Technologies, Inc.) ●
- K171390 dpl® II Panel (LED Technologies, Inc.) ●
- K171386 dpl® SpectraLite (LED Tchnologies, Inc.) ●
Predicate Chart
| Device | reVive® Perioral
LED Light Therapy
system
LED Technologies,
Inc.
KXXXXXXXXX | dpl® Nüve for
wrinkles
LED Technologies,
Inc.
K141181 | dpl® II Panel
LED Technologies,
Inc.
K171390 | dpl® SpectraLite
LED Technologies,
Inc.
K171386 |
|-------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------|
| Wavelengths | 605nm, 630nm,
660nm, 880nm | 605nm, 630nm,
660nm, 880nm | 605nm, 630nm,
660nm, 880nm | 605nm, 630nm,
660nm, 880nm |
| Irradiance source | LED | LED | LED | LED |
| Treatment Area | 24 cm² | 30 cm² | 415 cm² | 28 cm² |
| Energy Level | 67.7 mW/cm² | 62.07 mW/cm² | 70.16 mW/cm² | 61.59 mW/cm² |
5
| Treatment Time | 3 minutes per treatment | 3 minutes per treatment | 3 minutes per treatment | 3 minutes per treatment |
|---|---|---|---|---|
| Type/Class | OTC | OTC | OTC | OTC |
Summary of the technological characteristics of the device compared to predicate device:
-
- Has the same/similar intended use as the predicate device (i.e., treatment of wrinkles).
-
- Has the same/similar output (i.e., 67.7 mW/cm²) as the predicate devices;
-
- Utilizes the same number of wavelengths (i.e., 4 wavelengths between 605 nm 880 nm) as the predicate devices;
-
- Utilizes the same treatment duration (i.e., 180 seconds) as the predicate devices;
-
- Utilizes the same treatment regimen of five days a week for eight weeks.
The reVive® Perioral LED Light Therapy 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 similar with equal power output. Based upon comparison to the predicate devices, the reVive® Perioral LED Light Therapy system has the same intended uses, and similar technological characteristics as the predicate devices.
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 & dpl® II Panel, and same as used in dpl® SpectraLite.
The reVive® Perioral LED Light Therapy system is battery powered (LI-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. 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 reVive® Perioral LED Light Therapy system, included functional performance testing, and software validation testing.
Safety and functionality testing demonstrates that the reVive® Perioral LED Light Therapy system conforms to various international consensus standards.
6
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.
UL 1642 Battery Certification UN 38.3 Battery Certification.
Biocompatibility
ISO 10993-5:2009 – Cytotoxicity Test ISO 10993-10:2010 – Intracutaneous reactivity test ISO 10993-10:2010 – Skin Sensitization Test
The reVive® Perioral LED Light Therapy 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. Substantial Equivalence Discussion
After analysis of, 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.