(475 days)
Not Found
No
The summary describes a microcurrent electrical stimulation device controlled by a microprocessor, with no mention of AI, ML, image processing, or data sets for training or testing algorithms.
No.
The device's stated purpose is for "cosmetic use" and "aesthetic purposes," which falls outside the definition of a therapeutic device designed for treating diseases or injuries.
No
The device is described as a "Facial Toning Device" that "uses microcurrent electrical energy to stimulate facial tissues for aestheric purposes" and is "intended for facial stimulation." There is no mention of it being used to identify or diagnose any medical conditions.
No
The device description explicitly states it is "housed in a white plastic case" and mentions "battery voltage" and "line power," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for "facial stimulation for aesthetic purposes" and "prescription cosmetic use" on the "face." This clearly describes a device used on the body for cosmetic or therapeutic purposes, not for testing samples taken from the body to diagnose or monitor a medical condition.
- Device Description: The description focuses on the physical characteristics and operation of a device applied to the face.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information for the diagnosis or monitoring of a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Beautiful Image Model 900 Facial Toning Device uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes.
Biosonic Technologies Model 900 Facial Toning Device is intended for facial stimulation and is indicated for prescription cosmetic use. The anatomical site for application of the Model 900 is the face.
Product codes
NFO
Device Description
Beautiful Image Model 900 Facial Toning Device is intended for facial stimulation and is indicated for prescription cosmetic use. The anatomical site for application of the Model 900 is the face.
To enhance safety, the device is operated only from battery voltage and will not operate while connected to line power. A proper recharge should be performed prior to using the machine.
The Model 900 is microprocessor controlled and housed in a white plastic case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
the face.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription cosmetic 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)
Nonclinical Test Data:
Product Safety testing and electromagnetic compatibility testing conforming to IEC 60601-1 and IEC 60601-1-2, and biocompatibility testing conforming to ISO 10993 were performed in support of the overall safety and effectiveness characteristics of the device, and have confirmed that the Model 900 is safe, effective and substantially equivalent regarding the outputs of the predicate device.
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
§ 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
Section 005 - Traditional 510(k) Summary
As required in 21 CFR807.92, we hereby submit this Traditional 510(k) Summary.
Traditional 510(k) owners name, address, phone, fax, contact person & preparation date
The Traditional 510(k) owner is Biosonic Technologies, LLC.
- Address: 333 Las Olas Way, Suite 1906
Fort Lauderdale, FL 33311
Phone: (954) 300 - 2511
(866) 830 - 8759 Fax:
The contact person is Mr. Ray Baker, President, Biosonic Technologies, LLC.
Traditional 510(k) preparation date: 19 August, 2011
SUBJECT DEVICE:
Name of the device, trade name, proprietary name, and classification name:
Trade name: Beautiful Image Model 900 Facial Toning Device
Common name: Facial Toning Device
Classification: Stimulator, Transcutaneous Electrical, Aesthetic Purposes.
CFR Reference: 21 CFR 882.5890
Product Code: NFO
Device Description:
Beautiful Image Model 900 Facial Toning Device is intended for facial stimulation and is indicated for prescription cosmetic use. The anatomical site for application of the Model 900 is the face.
1
To enhance safety, the device is operated only from battery voltage and will not operate while connected to line power. A proper recharge should be performed prior to using the machine.
The Model 900 is microprocessor controlled and housed in a white plastic case.
| Dimensions & Appearance: | |
|---|---|
| Height (rear) | 5.5 inches (13.97 cm) |
| Height (front) | 3.3 inches (8.38 cm) |
| Width | 15.3 inches (38.86 cm) |
| Depth | 11.3 inches (28.7 cm) |
| Weight | 10.0 pounds (4.5 kgs) |
| Color | White case with blue front panel |
| Electrical Specifications | |
| Device power | Model 900 will operate only on battery power; it will |
| not operate on line voltage | |
| Device Output | 800µA maximum, from constant current source |
| Complex wave output frequency | 3 Hz to 300 Hz |
| Maximum voltage | 30Vpp on any output with respect to common; 5Vpp |
| typical | |
| Battery Charger | 9vdc @ 1 amp. Use of the charger disables the |
| patient circuits | |
| Battery | 6 volt, 7 amp hours |
| Power Requirements CAC | |
| Adapter | |
| Input Voltage | 100 to 120 VAC, 60 Hz |
| Input Current | 0.15 amps |
| Configuration | Standard U.S. 2-Prong Plug |
| Device output Voltage | 9v DC |
| Output Current | 1 amp |
| Output Plug | De coas: 5.5mm OD, 2.1mm pin receptacle |
| Cable length | 6 ft (240 cm) |
| Environmental Specifications | |
| Operating Temperature | + 50 to 104° F (+10 to +40°C) |
| Storage Temperature | - 29 to + 167° F (-34 to +76° C) |
| Humidity | 0 to 95% - non-condensing |
Specifications:
5-2
2
FUNCTIONAL DESCRIPTION
OPERATING CYCLE:
The Model 900 operating cycle is initiated by momentarily pressing the POWER button located in the POWER section of the front panel. All indicator lights (LEDs) on the panel will illuminate for a short period of time except for the CHARGING and the BATTERY LOW or BATTERY FULL indicators (depending on the charge level of the battery).
The INTERVAL PACE lights (located in the WAVEFORM section of the panel) will step from left to right providing a visual indication of the approximate delay time remaining prior to the application of energy to the probes. The INTERVAL DELAY adjustment sets the amount of time for this delay.
The SEQUENCING lights (also located in the WAVEFORM section of the panel) indicate the application of each of the different waveform outputs from the equipment, seven in total. The SEQUENCE DURATION adjustment sets the amount of time for the total sequenced set.
OPERATING RANGES:
Adjustment of the output energy intensity is set by the INTENSITY ADJUSTMENT button located in the PROCEDURE section of the panel. Each press of the button will advance the output energy from NORMAL, to MODERATE, to HIGH, and then the sequence will repeat.
The INTERVAL DELAY provides an adjustment range of approximately 1 to 6 seconds.
The SEQUENCE DURATION provides an adjustment range of approximately 10 to 30 seconds.
Waveform frequencies: automatically sequencing from 3 Hz to 300 Hz
OPERATING MODE:
An indicator shows that the wand set is in use. The indicator will be illuminated when the wand is connected to the machine.
CALIBRATION:
The Model 900 does not require calibration.
3
INDICATION FOR USE:
The Beautiful Image Model 900 Facial Toning Device uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes. INTENDED USE:
Biosonic Technologies Model 900 Facial Toning Device is intended for facial stimulation and is indicated for prescription cosmetic use. The anatomical site for application of the Model 900 is the face.
COMPARISON WITH THE PREDICATE DEVICE:
The predicate device for this Traditional 510(k) is the NūFace Facial Toning Device. The subject device is Biosonic Technologies Beautiful Image Model 900 Facial Toning Device, that is substantially equivalent to the predicate device, differing only in that the unit is larger and designed to support the handheld operation of the contacts from a desktop device by means of cables, and is intended for the use of licensed practitioners rather than the public.
COMPARISON OF THE SUBJECT DEVICE AND PREDICATE DEVICE PARAMETERS:
| Parameter | Your Device | Predicate
Device |
|-------------------------------------------------------------------------------------------------|----------------------------------|-----------------------|
| 510(k) Number | K130065 | K072260 |
| Device Name and Model | Model 900 | NuFace
Original |
| Manufacturer | Biosonic
Technologies,
LLC | Carol Cole
Company |
| Power Source(s) † | One 6V battery | One 9V battery |
| - Method of Line Current Isolation | N/A | N/A |
| - Patient Leakage Current†† | N/A | N/A |
| - Normal Condition (μΑ) | N/A | N/A |
| - Single Fault Condition (μΑ) | N/A | N/A |
| Average DC current through electrodes when
device is on but no pulses are being applied (µA) | None | None |
| Number of Output Modes ††† | One | One |
| Number of Output Channels†††† | One | One |
| Synchronous or Alternating? | N/A | N/A |
4
| Parameter | Your Device | Predicate Device |
|---|---|---|
| Method of Channel Isolation | N/A | N/A |
| Regulated Current or Regulated Voltage? | Both | Both |
| Software/Firmware/Microprocessor Control? | Yes | No |
| Automatic Overload Trip? | Yes | No |
| Automatic No-Load Trip? | Yes | No |
| Automatic Shut Off? | Yes | No |
| User Override Control? | Yes | Yes |
| Indicator Display Status | ||
| On/Off Display Status? | Yes | Yes |
| Low Battery? | Yes | No |
| Voltage/Current Level? | Yes | No |
| Timer Range (minutes) | None | None |
| Compliance with Voluntary Standards? | IEC 60601-1 | IEC 60601-1 |
| Compliance with 21 CFR 898? | Yes | Yes |
| Weight (lbs., oz.) | 10lbs | 0.5lbs |
| Dimensions (in.) [W x H x D] | 5.5x15.3x11.3 | 2.25x7x0.75 |
| Housing Materials and Construction | Thermoplastic | Thermoplastic |
† For AC line-powered devices, we recommend that you specify the line voltage and frequency, the method of line current isolation, and the measured patient leakage current. For battery-powered devices, we recommend that you specify the number, size and type of batteries.
++ We recommend that you follow IEC 60601-1 "Medical Electrical Equipment - Part 1: General Requirements for Safety" or an equivalent method to show that the levels of patient leakage current, measured under both normal and single fault conditions, are acceptable.
ttt For devices with more than one output mode, we recommend that you provide the information in Output Waveforms (see Section 7A above) and Output Specifications (see Section 7C below) for each output mode.
tttt For devices with more than one output channel, we recommend that you describe whether the outputs are delivered in a synchronous and/or alternating fashion and the method of achieving channel isolation.
| .
Parameter | - March Made de
문
. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.
Jevice | Predicate |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | | | Device |
| . B | of the first and a program of the company and any come and a | | |
| Parameter | | Your Device | Predicate
Device |
| Mode or Program Name | | Beautiful
Image | NuFace |
| | Waveform (e.g., pulsed monophasic, biphasic) | Biphasic | Pulsed
Monophasic |
| | Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Rectangular |
| | Maximum Output Voltage (volts) (+/- 5%) | 0.347 @500Ω | 0.16 @500Ω |
| | | 1.242 @ 2 kΩ | 0.78 @ 2 kΩ |
| | | 5.780 @10 kΩ | 2.6 @10 kΩ |
| | Maximum Output Current (mA) (+/- 5%) | 0.647 @500Ω | 0.324 @500Ω |
| | | 0.625 @ 2 kΩ | 0.358 @ 2 kΩ |
| | | 0.584 @10 kΩ | 0.263 @10 kΩ |
| Duration of primary (depolarizing) phase† (msec) See
Note 3 | | 0.648 - 322 | --- |
| Pulse Duration† (msec) | | 3.24 - 1610 | ---- |
| Frequency† (Hz) [or Rate† (pps)] | | 0.621 - 308.6 | ---- |
| For multiphasic | Symmetrical phases? | Yes | Yes / No |
| waveforms only: | Phase Duration† (msec),
(state range, if applicable),
(both phases, if asymmetrical | 0.324-161 | pulsed |
| Net Charge (micro coulombs (µC) per pulse) (If zero,
state method of achieving zero net charge.) | | 0μC @500Ω | N/A @500Ω |
| Maximum Phase Charge, (µC) | | 190 @500Ω | 18.13 @500Ω |
| Maximum Current Density, †† (mA/cm², r.m.s.) | | 1.486 @500Ω | 0.341 @500Ω |
| Maximum Average Current (average absolute value),
mA | | 0.493 @500Ω | @500Ω |
| Maximum Average Power Density, †† (W/cm²), (using
smallest electrode conductive surface area) | | 366E-6 @500Ω | 3.02μW@500Ω |
| Burst Mode | (a) Pulses per burst | N/A | 2.1 |
| (i.e., pulse trains): | (b) Bursts per second | N/A | 9.1 |
| | (c) Burst duration (seconds) | N/A | 2.3 |
| | (d) Duty Cycle: Line (b) x Line
(c) | N/A | 20.9 |
| ON Time (seconds) | | 10-30 | Constant |
| OFF Time (seconds) | | 1-6 | None |
| Additional Features (specify, if applicable) | | None | None |
5
† For continuously variable parameters, we recommend that you specify the full range; for parameters with discrete settings, we recommend that you specify all available selections.
tt We recommend that you calculate the maximum current density and maximum average power density values by using the conductive surface area of the smallest electrodes intended for use with the unit, and include sample calculations in your 510(k). We also recommend that you calculate the maximum power density by using the maximum duty cycle and by averaging over output duration of one second. The maximum average power density should be less than 0.25 watts per square centimeter of electrode conductive surface area to reduce the risk of thermal burns.
6
DISCUSSION OF WHY THE DIFFERENCES BETWEEN THE SUBJECT DEVICE AND THE PREDICATE DEVICE DO NOT ADVERSELY AFFECT SAFETY AND EFFECTIVENESS:
The predicate device has a 9v battery, while the subject device has a 6v battery. Generally, a lower voltage battery represents a lower risk factor, and this advantage counts in favor of the Model 900 while providing the device ample power to perform in its intended use. Furthermore, the predicate device does not have any software/firmware/microprocessor control, automatic overload trip, automatic no-load trip, automatic shutoff, low battery indicator display status, nor voltage/current level indicator display status. Each of these safety features exists within the subject device, and therefore provides a safer device than the predicate device. Additionally, the predicate device is much smaller and lighter than the robust Model 900, which will not as easily move about and is designed in this fashion in direct response to user design inputs. Regarding the current, the maximum current density of the Model 900 measures 1.486 mA/cm2 r.m.s. at 500 Ohms of resistance, versus the reported 0.341 mA/cm2 r.m.s. at 500 Ohms resistance of the NūFace, and although this appears to represent a difference within the overall current, it reflects simply a more precise surface contact area that applies the microcurrent as compared to the predicate. The overall current delivered from the Model 900 is unchanged. Finally, the maximum average power density is 366E-6 W at 500 Ohms versus 3.02 µW at 500 Ohms, which represents a larger energy output than the predicate, given the more precise surface contact area, while remaining as safe as the predicate, and more effective at the point of contact than the predicate. Thus, given the foregoing, the Model 900 is at least as safe and as effective as the predicate NūFace device.
All other parameters including the intended use and safety profile remain unchanged.
NONCLINICAL TEST DATA:
Product Safety testing and electromagnetic compatibility testing conforming to IEC 60601-1 and IEC 60601-1-2, and biocompatibility testing conforming to ISO 10993 were performed in support of the overall safety and effectiveness characteristics of the device, and have confirmed that the Model 900 is safe, effective and substantially equivalent regarding the outputs of the predicate device.
SUMMARY:
No new issues of safety or effectiveness are raised regarding the Model 900 Facial Toning Device.
End of Traditional 510(k) Summary Section
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 30, 2014
Biosonic Technologies, LLC c/o Shepard G. Bentley Bentley Biomedical Consulting, LLC 28241 Crown Valley Parkway, Suite 510(K) Laguna Niguel, CA 92677
Re: K130065
Trade/Device Name: Beautiful Image Model 900 Facial Toning Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: March 30, 2014 Received: April 1, 2014
Dear Mr. Bentley:
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 your do rise 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a dolly and regulations administered by other Federal agencies. You must of any I vith all the Act's requirements, including, but not limited to: registration and listing (21
8
Page 2 - Mr. Shepard G. Bentley
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/ReportalProblem/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.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K130065
Device Name
Beautiful Image Model 900 Facial Toning Device
Indications for Use (Describe)
The Beautiful Image Model 900 Facial Toning Device uses microcurrent electrical energy to stimulate facial tissues for aestheric purposes.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
.
ം Date: 2014.04.30
-0 16:54:05 -04'00'
10
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