(328 days)
Not Found
No
The device description and performance studies focus on the physical components (LEDs, power adapter, timer) and usability, with no mention of AI or ML algorithms for analysis, control, or any other function.
Yes
The device is intended for the treatment of full face wrinkles, which is a therapeutic purpose.
No
Explanation: The device is intended for the "treatment of full face wrinkles" using LED light therapy, not for diagnosing any medical condition.
No
The device description clearly outlines a physical, tabletop device with LEDs, a power adapter, a timer, and other hardware components. It is not solely software.
Based on the provided information, the Rejuvalite MD device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the treatment of full face wrinkles." This is a therapeutic use, not a diagnostic use. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a light therapy device that applies light to the skin. It does not involve the analysis of biological samples.
- Anatomical Site: The device is applied to the "full face," which is an external anatomical site. IVDs typically involve analyzing internal samples (blood, urine, tissue, etc.).
- No mention of biological samples or analysis: The description focuses on the physical characteristics of the device and its light output. There is no mention of collecting or analyzing any biological specimens.
Therefore, the Rejuvalite MD is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rejuvalite MD is an Over the Counter device that is intended for the treatment of full face wrinkles.
Product codes
OHS
Device Description
The Rejuvalite MD, is a tabletop device that contains 120 LEDs split evenly into 4 different wavelengths. The total power density for combined wavelengths is approximately 62 mW/cm2 at a distance of 4" from the illuminating surface of the device.
The labeling requires Users to maintain the distance between the illuminating surface and the treatment site at 4"during the treatment. There is a 4" distance limiting arm attached to the device to help users on determining and maintaining the 4" distance between the device's illuminating surface and the treatment site.
The Rejuvalite MD system components include the tabletop unit consisting of the base, arm, and swivel head containing the LED module , 4" distance limiting arm, timer, internal UL approved power adapter, and goggles.
The device incorporates a power adapter mounted inside of the lamp base that converts the AC to DC voltage. The power switch is operated to turn the device on or off.
The unit is designed to be placed on a table for easy exposure to the face 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
full face
Indicated Patient Age Range
Not Found
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
A Usability/Label Comprehension Study was conducted with 36 participants.
The results of the study found that: 97% of the participants were able to comprehend the labeling. 100% of the participants were able to use the device successfully.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be made of flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
Trophy Skin Incorporated % Ms. Susan R. Anthoney-DeWet AEGIS Regulatory Incorporated 2424 Dempster Drive Coralville, Iowa 52241
Re: K133896 Trade/Device Name: Rejuvalite MD 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: October 6, 2014 Received: October 7, 2014
Dear Ms. Anthoney-DeWet:
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
- 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) K133896
Device Name Rejuvalite MD
Indications for Use (Describe)
The Rejuvalite MD is an Over the Counter device that is intended for the treatment of full face wrinkles.
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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
K133896
This summary of 510(k) summary information is being submitted in accordance with the requirements of 21 CFR § 878.4810.
Submission Date: December 11, 2013
| 1. Submitter Information: | AEGIS Regulatory, Inc. - Robert T. Wagner
2424 Dempster Drive
Coralville, IA 52241
Tel.: 865-982-5552
Email: bob@fdalistingconsultants.com |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| For Sponsor: | Trophy Skin, Inc.
Attn: Imran Karim
4372 Kenmare Trail
Frisco, TX 75034
Tel.: 469-698-6270
Fax: 972-692-7194
Email: trophyskin@gmail.com |
2. General Information
- 2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction Device
- 2.2 Common/Usual Name: Rejuvalite MD
- 2.3 Proprietary Names: Rejuvalite MD
- 2.4 Classification: Class II
- 2.5 Classification Number: 878.4810
- 2.6 Product Code: OHS
- 2.7 Review Panel: General & Plastic Surgery
4
3. Device Description:
The Rejuvalite MD, is a tabletop device that contains 120 LEDs split evenly into 4 different wavelengths. The total power density for combined wavelengths is approximately 62 mW/cm2 at a distance of 4" from the illuminating surface of the device.
The labeling requires Users to maintain the distance between the illuminating surface and the treatment site at 4"during the treatment. There is a 4" distance limiting arm attached to the device to help users on determining and maintaining the 4" distance between the device's illuminating surface and the treatment site.
The Rejuvalite MD system components include the tabletop unit consisting of the base, arm, and swivel head containing the LED module , 4" distance limiting arm, timer, internal UL approved power adapter, and goggles.
The device incorporates a power adapter mounted inside of the lamp base that converts the AC to DC voltage. The power switch is operated to turn the device on or off.
The unit is designed to be placed on a table for easy exposure to the face 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 RejuvaliteMD is an Over -the- Counter device that is intended for the use in the
treatment of full face wrinkles.
Rx or OTC:
The Rejuvalite MD device is an Over the Counter (OTC) device. The labeling, instructions, and User Operations (21 CFR § 801.60 and 61), are designed for layman understanding and use. The predicate device is OTC.
5. Predicate Device (s):
This device is substantially equivalent to the following predicates, which are currently in safe
and effective commerce:
1. K120775 - LightStim for Wrinkles (LED Intellectual)
5
Predicate Comparison Chart
| Device | Rejuvalite MD | LightStim for
Wrinkles |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| | Trophy Skin | LED Intellectual |
| | K133896 | K120775 |
| | This Submission | A Predicate Device |
| Indications | The RejuvaliteMD
is an Over the
Counter device that
is intended for the
use in the treatment
of full face wrinkles. | The Lightstim for
Wrinkles is an OTC
hand-held device
intended for the use
in the treatment of
full-face wrinkles |
| Handheld | Table top | Yes |
| Wavelengths | 600,622,660,860nm | 605,630,660,855nm |
| Modes | On/Off | On/Off |
| Energy Source | 120 LEDs. Over
90cm2 | 72 LEDs. Over
40cm2 |
| Total Power
Density | 62 mW/cm2 at a
distance of 4" from
the LED head | 62 mW/cm2 in
contact with LED
head |
| Power Supply | AC to DC | 9-volt DC power
transformer |
| Treatment
Regime | 3 minutes daily, 5
days per week for 8
weeks | 3 minutes daily, 5
days per week for 8
weeks |
| Target
Population | Individuals with
wrinkles on the face | Individuals with
wrinkles on the face |
| Location for
Use | OTC | OTC |
Summary of the technological characteristics of the device compared to predicate device:
The predicate device K120775 (LightStim for Wrinkles) has a smaller surface area with fewer LEDs than the proposed Rejuvalite MD device, but number of wavelengths, treatment duration, treatment regime and amount of energy (irradiance per area) delivered to the skin are the same.
6
This device also differs from the predicate device K120775 (LightStim for Wrinkles) in that it is not a handheld device in contact with the skin. The Rejuvalite MD is used at a 4" distance from the illuminated surface, but the power density per wavelength (mW/cm2), total power density of combined wavelengths (62 mW/cm2), amount of energy (irradiance per area) delivered to the skin measured at 4" are identical to the predicate device . The method of operation of the Rejuvalite MD device is similar to the predicate device K120775 (LightStim for Wrinkles) in that both devices have no software and use an On/Off switch.
No adverse effects on any of the predicate devices were found in MAUDE since clearance in 2005.
After analysis of safety, indications, intended uses, power density per wavelength (mW/cm2) , total power density of combined wavelengths (62 mW/cm2), performance, features, design materials, , technological properties, treatment areas, treatment reqimes and methods of operation, the manufacturer asserts that no significant differences exist between the applicant device and predicates listed in the predicate chart, and no new issues arise for safety and effectiveness. Therefore, substantial equivalency is hereby requested.
6. Biocompatibility:
The only patient contact material in the Reiuvalite MD is the body of the device.
The body of the device is constructed of ABS plastic, the same material used in the predicate device. The biocompatibility of this material is well known and considered safe when in contact with healthy skin.
The conclusion is that the Rejuvalite MD does not raise any new safety issues.
7. Performance Testing and Standards:
This device has been tested under and are in compliance with performance standards that have
been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act.
Safety and functionality testing demonstrates that the Rejuvalite MD conforms to various international consensus standards:
IEC 60601-1: (2005) +Corr. 1 (2006) + Corr. + (2007): 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
7
Performance Testing on optical and electrical characteristics demonstrated that the Rejuvalite MD device is almost identical to that of the predicate devices.
A Usability/Label Comprehension Study was conducted with 36 participants.
The results of the study found that: 97% of the participants were able to comprehend the labeling. 100% of the participants were able to use the device successfully.
The conclusions drawn from nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices.
8. Statement of Safety and Effectiveness:
The information in this 510(k) submission was used to support the safety and effectiveness of this device with respect to its cited predicates.
9. Substantial Equivalence Discussion
After analysis of safety, indications, intended uses, power density (mW/cm2) per wavelength, total power density of combined wavelengths (62 mW/cm2), performance, features, design materials, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer asserts that no significant differences exist between the applicant device and predicates listed in the predicate chart, and no new issues arise for safety and effectiveness. Therefore, substantial equivalency is hereby requested.