(71 days)
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on LED light therapy and a cleansing function.
Yes.
The device is intended for the treatment of wrinkles and mild to moderate inflammatory acne, which are therapeutic applications.
No
The device is intended for treatment (wrinkles and acne) and cleansing, not for diagnosis.
No
The device description explicitly states it is an "over-the counter light emitting diode (LED) device" and lists physical components such as the device containing the LED module, USB power cord, power adapter, and cleansing brush-heads. 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 the treatment of wrinkles and mild to moderate inflammatory acne. This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an LED light therapy device applied directly to the skin for treatment. It also has a cleansing function. This description aligns with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
Therefore, the reVive Light Therapy LED Cleansing System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The reVive Light Therapy® LED Cleansing System is intended for treatment of wrinkles and mild to moderate inflammatory acne.
Product codes
OHS, 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 wrinkles and mild to moderate inflammatory acne, as defined in 21 CFR § 878.4810.
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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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".
The Testing confirmed that modifications made to the device were correctly implemented and that the device 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 27, 2022
LED Technologies, Inc. Jelena Barbaric Compliance Manager 12821 Starkey Rd., Suite 4900 Largo, Florida 33773
Re: K221430
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, OLP Dated: July 13, 2022 Received: July 15, 2022
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.
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
1
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 801and Part 809); 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 medical devices and radiation-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,
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221430
Device Name reVive Light Therapy® LED Cleansing System
Indications for Use (Describe) The reVive Light Therapy LED Cleansing System is intended for treatment of wrinkles and mild to moderate inflammatory acne.
| 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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510 (k) Summary K221430
This summary of 510 (k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submission Date: May 17th, 2022
-
- Submitter Information: LED Technologies, Inc. - Jelena Barbaric 12821 Starkey Rd., Suite 4900 Largo, FL 33773 Tel: 303-845-0028 Email: jbarbaric@ledtechnologies.com
For Specification Developer: LED Technologies, Inc. Attn: Lloyd Nelson 12821 Starkey Rd., Suite 4900 Largo, FL 33773 Tel.: 303-748-0545 Email: Inelson@ledtechnologies.com
- Submitter Information: LED Technologies, Inc. - Jelena Barbaric 12821 Starkey Rd., Suite 4900 Largo, FL 33773 Tel: 303-845-0028 Email: jbarbaric@ledtechnologies.com
2. General Information
- 2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction/Over-The-Counter Light-Based Laser for Acne
- 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/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 wrinkles and mild to moderate inflammatory acne, as defined in 21 CFR § 878.4810.
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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 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 intended for treatment of wrinkles and 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 OHS/OLP:
K180445 - The reVive Light Therapy® LED Cleansing System (LED Technologies, Inc.)
K180447 – The reVive Light Therapy® LED Cleansing System (LED Technologies, Inc.)
| | New Device
K221430 | Predicate Device
K180445 | Predicate Device
K180447 |
|----------------------|---------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------|
| Wavelengths | Wrinkle Treatment:
605nm
630nm
660nm
880nm
Acne Treatment:
415nm
630nm | 605nm
630nm
660nm
880nm | 415nm
630nm |
| Irradiance
Source | LED | LED | LED |
| Treatment
Area | 18.86 cm² | 18.86 cm² | 18.86 cm² |
| Treatment
Method | Place device directly
on the skin | Place device directly on
the skin | Place device directly
on the skin |
| Treatment
Time | 3 minutes | 3 minutes | 3 minutes |
Comparison Chart
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| Material | ABS | ABS | ABS |
|---|---|---|---|
| Power Source | 3.7 V Lithium Battery | 3.7 V Lithium Battery | 3.7 V Lithium Battery |
| Type/Class | OTC | OTC | OTC |
| IFU | Treatment of | ||
| wrinkles and mild to | |||
| moderate | |||
| inflammatory acne | Treatment of wrinkles | Treatment of mild to | |
| moderate | |||
| inflammatory acne |
6. Testing
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".
The Testing confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices.
7. Conclusion
In sum, the only modification introduced is the updated software and associated hardware. All other features including the technological characteristics, material, treatment method, treatment time, and the intended uses of a new device are identical to that of the cleared devices. The introduced modification does not present changes to the fundamental scientific technology and essential parameters of the originally cleared predicate devices.
Testing confirmed that the performance of the reVive Light Therapy® LED Cleansing System meets the product system requirements, which is based on the predicate devices. Therefore, the modification resulted in a device that performs the same as the predicate devices.