(33 days)
Not Found
No
The description focuses on LED light therapy and does not mention any AI or ML components or functionalities. The software validation mentioned is standard for medical device software and doesn't indicate AI/ML.
Yes.
The document states its intended use is for the "treatment of wrinkles and mild to moderate inflammatory acne," which directly refers to therapeutic applications. Furthermore, it refers to a CFR section for "powered dermatological surgical instruments" (21 CFR § 878.4810), which are therapeutic devices.
No
The device is intended for treatment of wrinkles and acne, not for diagnosis. Its description focuses on emitting energy for treatment, not for identifying or characterizing a medical condition.
No
The device description explicitly states that the device components include a device containing an LED module, which is a hardware component. The summary also describes the device being applied directly to the skin, further indicating a physical 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 acne, which is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an LED light therapy device applied directly to the skin. It does not involve the analysis of biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
The device falls under the category of a therapeutic medical device, specifically a light-based device for dermatological treatment.
N/A
Intended Use / Indications for Use
The reVive Light Therapy® Wrinkle and Acne LED Device is intended for treatment of wrinkles and mild to moderate inflammatory acne.
Product codes
OHS, OLP
Device Description
The reVive Light Therapy® Wrinkle and Acne LED Device 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.
The reVive Light Therapy® Wrinkle and Acne LED Device components include the device containing the LED module.
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
The reVive Light Therapy® Wrinkle and Acne LED Device 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
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.
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 21, 2022
LED Technologies, Inc. Jelena Barbaric Official Correspondent 12821 Starkev Rd.. Suite 4900 Largo, Florida 33773
Re: K223482
Trade/Device Name: reVive Light Therapy® Wrinkle and Acne LED Device 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: November 18, 2022 Received: November 18, 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 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 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,
Image /page/1/Picture/5 description: The image shows the text "Jianting Wang -S" in a large, sans-serif font. The text is black and is set against a white background. The name "Jianting Wang" is followed by a hyphen and the letter "S". The text is centered horizontally and vertically in the image.
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) K223482
Device Name
reVive Light Therapy® Wrinkle and Acne LED Device
Indications for Use (Describe)
The reVive Light Therapy® Wrinkle and Acne LED Device 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)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) Summary
K223842
This summary of 510 (k) information is being submitted in accordance with the requirements of 21 CFR § 807.92.
Submission Date: November 18th, 2022
| 1. 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
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® Wrinkle and Acne LED Device
- 2.3 Proprietary Names: reVive Light Therapy® Wrinkle and Acne LED Device
- 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® Wrinkle and Acne LED Device 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.
4
The reVive Light Therapy® Wrinkle and Acne LED Device components include the device containing the LED module.
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® Wrinkle and Acne LED Device is an Over the Counter (OTC) LED device intended for use in treating wrinkles and mild to moderate inflammatory acne.
4. Predicate Device
This device is substantially equivalent to the following predicates, which are currently in safe and effective commerce under product codes OHS/OLP:
K210965 – The reVive Light Therapy® Essentials (LED Technologies, Inc.) K210968 – The reVive Light Therapy® Essentials (LED Technologies, Inc.)
Comparison Chart
| | New Device
KXXXXXXXX | Predicate Device
K210965 | Predicate Device
K210968 |
|----------------------|---------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------|
| Wavelengths | Wrinkle Treatment:
605nm
630nm
660nm
880nm
Acne Treatment:
415nm
630nm | 605nm
630nm
660nm
880nm | 415nm
630nm |
| Irradiance
Source | LED | LED | LED |
| Treatment
Area | 7 cm² | 7 cm² | 7 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 |
| Material | ABS | ABS | ABS |
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| Power Source | Battery or Universal
USB power source | Battery or Universal USB
power source | Battery or Universal
USB power source |
|--------------|-----------------------------------------------------------------------|------------------------------------------|-------------------------------------------------------|
| 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 |
5. Testing
The reVive Light Therapy® Wrinkle and Acne LED Device 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.
6. 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® Wrinkle and Acne LED Device 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.