(48 days)
Not Found
Not Found
No
The device description details a simple microprocessor-controlled sequence of electrode activation with no mention of learning, adaptation, or complex data processing characteristic of AI/ML.
No
The device is indicated for cosmetic use, not therapeutic use. While the description mentions clinical efficacy and safety data, its stated primary purpose is cosmetic.
No
The "Intended Use / Indications for Use" section explicitly states that "The Rejuvenique System is indicated for cosmetic use," which is not a diagnostic purpose.
No
The device description clearly outlines hardware components including a face mask, connecting cable, and control unit with a power source and microprocessor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "cosmetic use." IVDs are intended for the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Device Description: The device description details a system that applies electrical stimulation to the face for toning. This is a physical intervention, not a test performed on specimens derived from the human body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVDs.
Therefore, the Rejuvenique System, as described, falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Rejuvenique® System is indicated for cosmetic use.
Product codes (comma separated list FDA assigned to the subject device)
NFO, GYB
Device Description
The Rejuvenique facial toning system consists of three connected components a face mask, connecting cable and control unit. The mask is a PBC mask that is shaped to fit over the user's face. It is held on the user's face by an adjustable headband. It contains 26 fixed-position, gold plated, brass electrodes. The connecting cable is an 8-conducter cable in a PVC jacket. It connects the face mask to the control unit by modular, phone jack-style plugs on each end. The Control Unit contains the power-source ( a nine-volt battery), and the microprocessor control.
When the Rejuvenique® system is activated, it provides a stimulus to the first pair of electrodes for 20 seconds, and then the microprocessor automatically switches to the next pair of electrodes in the sequence. The Facial Point Location Display indicates which pair of electrodes are currently activated (1-12). A full cycle through the 12 pairs of electrodes requires approximately 4 minutes. Unless stopped by the user the product will go through four complete cycles (approximately 20 minutes), and then automatically shuts off.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Clinical efficacy and safety data was submitted in the application.
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.
Not Found
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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
AUG = 8 2001
510(k) SUMMARY REJUVENIQUE® FACIAL TONING SYSTEM
Applicant/Address
- Salton, Inc., 1955 W. Field Court, Lake Forest, IL 60045 ם
Contact Person/Telephone
- Leon Dreimann, Chief Executive Officer, (PH) 847-803-4600 ext. 1200; (FAX) 847-803-1211
Preparation Date
- 2001 August 7, 2001
Device Trade Name
- Rejuvenique® o
Classification Name
- TENS Device(21 CFR 882.5890)
Legally Marketed Predicate Devices
- a TENS devices.
Device Description
- The Rejuvenique facial toning system consists of three connected components a face ם mask, connecting cable and control unit. The mask is a PBC mask that is shaped to fit over the user's face. It is held on the user's face by an adjustable headband. It contains 26 fixed-position, gold plated, brass electrodes. The connecting cable is an 8-conducter cable in a PVC jacket. It connects the face mask to the control unit by modular, phone jack-style plugs on each end. The Control Unit contains the power-source ( a nine-volt battery), and the microprocessor control.
- When the Rejuvenique® system is activated, it provides a stimulus to the first pair of electrodes for 20 seconds, and then the microprocessor automatically switches to the next pair of electrodes in the sequence. The Facial Point Location Display indicates which pair of electrodes are currently activated (1-12). A full cycle through the 12 pairs of electrodes requires approximately 4 minutes. Unless stopped by the user the product will go through four complete cycles (approximately 20 minutes), and then automatically shuts off.
1
Intended Use
- ロ Rejuvenique® is indicated for cosmetic use.
Substantial Equivalence Summary
- O Rejuvenique® is substantially equivalent to legally marketed TENS devices.
Technological Characteristics
Basic Unit Characteristics
| 1. Power Source(s): | Single 9V Battery | |
|---|---|---|
| 2. Number of Output Modes: | 1 | |
| 3. | Number of Output Channels: | 1 channel |
| - Synchronous or Alternating? | Alternating into 12 electrode groups | |
| - Method of Channel Isolation | Electrode group selected by relays | |
| 4. Regulated Current or Voltage? | Regulated Voltage | |
| 5. | Software/Firmware/Microprocessor Control? | Yes |
| 6. Automatic Overload Trip? | No | |
| 7. | Automatic No-Load Trip? | No |
| 8. Automatic Shut Off? | Yes | |
| 9. | Patient Override Control? | Yes |
| 10. Indicator Display: | ||
| - On/Off Status? | Yes | |
| - Low Battery? | Yes | |
| - Voltage/Current Level? | Yes, Uncalibrated Knob | |
| 11. Timer Range (minutes) | Fixed 16 minutes | |
| 12. Compliance with 21 CFR 898 | Yes | |
| 13. Weight | 80 grams | |
| 15. Dimensions (in.) [WxHxD] | 4-1/2" x 3" x 1-1/4 | |
| 16. Housing Materials and Construction | ABS Plastic, snap latch assembly |
Output Specifications
| 1. Waveform: | Pulsed Biphasic |
|---|---|
| 2. Shape: | Rectangular (+ phase), Spike (- phase) |
| 3. Maximum Output Voltage: | 18.8V @ 500 Ohms |
| 4. (+/- 10 %) | 24.8V @ 2k Ohms |
| 5. | 28.0V @ 10k Ohms |
| 6. Maximum Output Current: | 37.6mA @ 500 Ohms |
| 7. (+/- 10 %) | 12.4mA @ 2k Ohms |
| 8. | 2.8mA @ 10k Ohms |
| 9. Pulse Width | 300 microseconds fixed |
| 10. Frequency (Hz) | 8 Hz fixed |
| 11. Beat Frequency (Hz) | N/A |
| 12. Symmetrical Phases | No |
2
-
- Phase Duration: (both phases, if asymmetrical)
- Net Charge (microC per pulse) 14. (if zero, state method to achieve)
- ાં રેં. Maximum Phase Charge, (microC)
- Maximum Current Density 16.
300 microseconds (+ phase) 124.7 milliseconds (- phase, exponential) 0 @ 500 Ohms Transformer Coupling 11.3 microCoulombs @ 500 Ohms 46.4 mA/cm2 @ 500 Ohms
Sample Calculation:
Jmax = Imax/(pi * D2/4) = 37.6 mA/(3.1416 * (1.016 cm)^2 / 4) = 46.4 mA/cm2 Assumes only one electrode pair contacting. If both pairs make contact, Jmax is 23.2 mA/cm-
Maximum Power Density, (W/cm2) 17.
2.31 mW/cm2
Sample Calculation:
Pmax = Jmax * Vmax * 0.3 ms/125 ms + V- * J- * 2.8 ms/125 ms Pmax = 46.4 mA/cm2 * 18.8 * 0.0024 + 2.0V * 4.93 mA/cm2 * 0.0224 Pmax = 2.093 mW/cm2 + 0.221 mW/cm2 = 2.31 mW/cm2 First portion is positive phase, second is negative phase. Assumes negative Phase is square shaped with constant amplitude equal to initial negative spike. This slightly overestimates the power density of the negative phase.
- Burst Mode: 18. 160 pulses a. Pulses per burst 1/240 (per electrode group) b. Bursts per second c. Burst duration 20 seconds d. Duty Cycle 1/12
On Time (Seconds) 19.
20 seconds/electrode group
Testing
- Clinical efficacy and safety data was submitted in the application.
Conclusion
- o Based on the foregoing, Salton believes the Rejuvenique® facial toning system is substantially equivalent to legally marketed predicate TENS devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Georgia C. Ravitz Counsel for Salton, Inc. Arent Fox Kinter Plotkin & Kahn, PLLC 1050 Connecticut Avenue, NW Washington, DC 20036-5339
Re: 510(k) Number K011935 Trade/Device Name: Rejuvenique® System, Model RJV-10 Regulation Numbers: 21 CFR 882.5890 and 21 CFR 882.1275 Regulatory Class: II Product Codes: NFO and GYB Dated: June 20, 2001 Received: June 21, 2001
Dear Ms. Ravitz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
AUG - 8 2001
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Georgia C. Ravitz
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2T CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
David C. Schultz, M.D.
Daniel G. Schultz, M.D. Deputy Director for Clinical and Review Policy Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page__1 __of__1
510(k) Number (if known): ___K011935
Device Name: Rejuvenique® System, Model RJV-10
Indications For Use:
The Rejuvenique System is indicated for cosmetic use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Mullens
Collig35
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number _