(397 days)
Not Found
No
The device description and performance studies focus on standard electrical and light-based therapies with fixed parameters, and there is no mention of AI, ML, or adaptive algorithms.
Yes
The device is intended for the treatment of periorbital wrinkles (red light mode) and the treatment of mild to moderate acne (blue light mode), which are therapeutic indications. While it also has an aesthetic mode (micro current for facial stimulation), the therapeutic claims qualify it as a therapeutic device.
No
Explanation: The device is described as providing stimulation for aesthetic use and treatment for wrinkles and acne, which are therapeutic and cosmetic functions. There is no mention of the device being used to identify, measure, or monitor a medical condition.
No
The device description clearly outlines physical components like electrodes and LEDs, and the performance studies include electrical safety and photobiological safety testing, indicating it is a hardware device with embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The described device uses microcurrent stimulation and light irradiation (red and blue light) applied externally to the face. It does not analyze samples taken from the body.
- Intended Use: The intended uses are for facial stimulation, treatment of periorbital wrinkles, and treatment of mild to moderate acne. These are all external applications and not diagnostic tests performed on samples.
- Device Description: The description details electrodes and LEDs for external application, not components for sample analysis.
Therefore, this device falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use.
For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles,
For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.
Product codes (comma separated list FDA assigned to the subject device)
NFO, OHS, OLP
Device Description
There are Micro current electrodes, Red LEDs, Blue LEDs in the treatment head for their individual treatment function. The device is provided with three operating function modes: Micro current stimulation mode, Red light irradiation mode, Blue light irradiation mode. Three operation modes can be selected by the "Mode" button. These modes only can work separately.
For Micro current stimulation mode:
The device has two pairs of electrode contactors for facial stimulation by applying an electrical micro current to electrodes. The output waveform is formed of regulated Voltage of Biphasic pulse and provided with 5 levels of output intensity, which can be adjusted by user.
The device requires the use of conductive gel provided together with the device.
For LED phototherapy function:
The device also can provide specific photon spectrum by LED lamps for Red light irradiation mode and Blue light irradiation mode. There are Red LED lamps and Blue LED lamps assembled in the treatment head.
In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit red light. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of red light is 630±10nm and its power density is 80 mW/cm2.
In Blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of blue light is 415 ±10 nm and its power density is about 50 mW/cm².
For the facial stimulation model, the recommend treatment session is 10 minutes/2 to 3 times per week.
For light irradiation of red light, the recommend treatment session is 3 minutes/ 2-3 times per week. And for blue light, the recommend treatment session is 4 minutes/ 2 times per week on each treatment area.
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
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)
EP-300 has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1:2005 +A1:2012 and IEC 60601-2-10: 2012 standards
- Electromagnetic compatibility test according to standard IEC 60601-1-2: 2014
- Photo biological safety of LED lamp systems according to IEC62471:2006
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- Waveform test report to verify the output specifications of the device according to IEC 60601-2-10:2012 and Guidance for Powered Muscle Stimulator.
- Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use according to IEC60601-2-57:2011
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.
K130065, K142794, K121435, K141308
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2017
Li-tek Electronic Technology Corporation % Mr. Jet Li Regulation Manager Guangzhou Leta Testing Technology Co., Ltd 6f, No.1 Tiantai Road, Science City, Luogang District Guangzhou, China
Re: K162652
Trade/Device Name: Smart Photon Micro-current Device: EP-300 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO, OHS, OLP Dated: September 14, 2017 Received: September 19, 2017
Dear Mr. Li:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/ResourcesforYou/Industry/default.htm. 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
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.
Sincerely, Jennifer R. Stevenson -
S3 For 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162652
Device Name
Smart Photon Micro-current Device, Model: EP-300
Indications for Use (Describe)
For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use.
For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles,
For blue light irradiation mode: The blue light is for the treatment of mild to moderate 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)
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 Druq 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."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
3
Chapter 6.510(k) Summary
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: October 25, 2017
There is no prior submission for the device.
2. Submitter's Information
510(k) Owner's Name: Li-Tek Electronic Technology Corporation
Establishment Registration Number:
Address: No.8~13, the industrial park of Jinshagang, Shixiavillage, Dalangtown, Dongguancity, Guangdong, China
Phone: 0769-83117755
Fax: 0769-83117759
Contact Person: Barry Yuan (Quality Director)
E-mail: quality5@li-tek.com
Application Correspondent:
Company: Guangzhou LETA Testing Technology Co., Ltd.
Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity, China
Contact Person: Mr. Jet Li
Tile: Regulation Manager
Tel: +86-20-22325619
Email: med-jl@foxmail.com
4
3. Subject Device Information
Type of 510(k) submission: Traditional
Common Name: Light based over the counter wrinkle reduction; over-the-counter powered light based laser for acne; stimulator, transcutaneous electrical, aesthetic purposes.
Trade Name: Smart Photon Micro-current Device, Model: EP-300
Classification Name: Light Based Over the Counter Wrinkle Reduction; Stimulator,
Transcutaneous Electrical, Aesthetic Purposes; Over-the-counter powered light based laser for acne.
Review Panel: General & Plastic Surgery, Neurology
Product Code: OHS, NFO, OLP
Regulation Number: 878.4810, 882.5890
Regulation Class: 2
4. Predicate Device Information
| Sponsor | Biosonic
Technologies, LIC. | EVERYWAY
MEDICAL
INSTRUMENT CO.,
LTD. | Home Skinovations
Ltd. | Nutra Luxe MD,
LLC |
|----------------------|------------------------------------------------------|------------------------------------------------|---------------------------|-----------------------|
| Device
Name | Beautiful Image
Model 900 Facial
Toning Device | MT-200 Facial
MENS | Silkn Blue | Nutra Light Red |
| 510(k)
Number | K130065 | K142794 | K121435 | K141308 |
| Product
Code | NFO | NFO | OLP | OHS |
| Regulation
Number | 882.5890 | 882.5890 | 882.5890 | 878.4810 |
| Regulation
Class | 2 | 2 | 2 | 2 |
-
- Device Description
5
There are Micro current electrodes, Red LEDs, Blue LEDs in the treatment head for their individual treatment function. The device is provided with three operating function modes: Micro current stimulation mode, Red light irradiation mode, Blue light irradiation mode. Three operation modes can be selected by the "Mode" button. These modes only can work separately.
For Micro current stimulation mode:
The device has two pairs of electrode contactors for facial stimulation by applying an electrical micro current to electrodes. The output waveform is formed of regulated Voltage of Biphasic pulse and provided with 5 levels of output intensity, which can be adjusted by user.
The device requires the use of conductive gel provided together with the device.
For LED phototherapy function:
The device also can provide specific photon spectrum by LED lamps for Red light irradiation mode and Blue light irradiation mode. There are Red LED lamps and Blue LED lamps assembled in the treatment head.
In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit red light. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of red light is 630±10nm and its power density is 80 mW/cm2.
In Blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of blue light is 415 ±10 nm and its power density is about 50 mW/cm².
For the facial stimulation model, the recommend treatment session is 10 minutes/2 to 3 times per week.
For light irradiation of red light, the recommend treatment session is 3 minutes/ 2-3 times per week. And for blue light, the recommend treatment session is 4 minutes/ 2 times per week on each treatment area.
5. Intended Use / Indications for Use
For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use.
For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles,
6
For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.
6. Test Summary
EP-300 has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to IEC 60601-1:2005 +A1:2012 and IEC 60601-2-10: 2012 standards
- � Electromagnetic compatibility test according to standard IEC 60601-1-2: 2014
- � Photo biological safety of LED lamp systems according to IEC62471:2006
- ◆ Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- � Waveform test report to verify the output specifications of the device according to IEC 60601-2-10:2012 and Guidance for Powered Muscle Stimulator.
- ◆ Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use according to IEC60601-2-57:2011
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of EP-300 is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements
of
Comparison | Subject
Device | Predicate
Device | Predicate
Device | Predicate
Device | Predicate
Device | Re
mark | |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----|
| | Basic Unit Characteristics | | | | | | |
| Device
Name
and | Smart Photon
Micro-current | Beautiful
Image Model 900 | MT-200
Facial | Silkn Blue | Nutra Light Red | -- | |
| Elements
of
Comparison | Subject
Device | Predicate
Device | Predicate
Device | Predicate
Device | Predicate
Device | Remark | |
| Model | Device, Model:
EP-300 | Facial Toning
Device | MENS | | | | |
| 510 (K)
Number | Applying | K130065 | K142794 | K121
435 | K141308 | -- | |
| Product
Code | NFO,
OHS, OLP | NFO | NFO | OLP | OHS | -- | |
| Regulation
Number | 882.5890,
878.4810 | 882.5890 | 882.5890 | 878.4810 | 878.4810 | -- | |
| Intended
Use | For micro
current
stimulation
mode: The
device is
intended for
facial
stimulation
and is
indicated for
over-the-
counter
aesthetic use.
For red light
irradiation
mode: The red
light is
intended for
the treatment
of periorbital
wrinkles, | Biosonic
Technologies
Model 900 Facial
Toning Device is
intended for facial
stimulation and is
indicated for
prescription
aesthetic use. The
anatomical site for
application of the
Model 900 is the
face. | The
Everyway
Facial
MENS,
model: MT-200 is
intended for facial
stimulation
and
indicated for over-
the-counter
aesthetic use. | The Silkn Blue is
indicated as an over
the
counter
phototherapy device
for the treatment of
mild to moderate
acne | The Nutra Light Red
is a non-invasive
LED light device is
intended/indicated
for over- the -
counter use for the
treatment of
periorbital wrinkles,
and rhytides. | SE | |
| Elements
of
Comparison | Subject
Device | Predicate
Device | Predicate
Device | Predicate
Device | Predicate
Device | Remark | |
| | For blue light
irradiation
mode: The
blue light is for
the treatment
of mild to
moderate
acne. | | | | | | |
| Apply parts | Face | Face | Face | Face | Face | SE | |
| Power
Sources | 3.7V, 800mAh
rechargeable
lithium battery | One 6V battery | 9-Volt battery | batteries | 4
rechargeable
batteries | SE
Note 1 | |
| Method of Line
Current
Isolation | Battery Supply
N/A | N/A | Type BF | N/A | N/A | SE
Note 1 | |
| | For Micro current facial stimulation function | | | | | | |
| Number of
Modes for
Micro current
stimulation | 1 | 1 | 3 (8Hz, 9Hz, 10Hz) | N/A | N/A | SE | |
| Number of
Channels for
Micro current
stimulation | 1 | 1 | 1 | N/A | N/A | SE | |
| -Synchronous
or Alternating | Alternating | N/A | Alternating | -- | N/A | SE | |
| Regulated
Current
or
Regulated
Voltage | Regulated
Voltage | Both | 0-3mA (load 4kΩ) | Regulated Voltage | N/A | SE | |
| Software/Firm
ware/Micropro | Yes | Yes | Yes | Yes | Yes | SE | |
| Elements
of
Comparison | Subject
Device | Predicate
Device | Predicate
Device | Predicate
Device | Predicate
Device | Remark | |
| cessor control | | | | | | | |
| Automatic
Overload Trip | Yes | Yes | Yes | -- | N/A | SE | |
| Automatic No-
load Trip | Yes. | Yes | Yes | -- | N/A | SE | |
| Automatic
Shut Off | Yes. | Yes | Yes | -- | N/A | SE | |
| Patient
Override
Control | Yes | Yes | -- | -- | N/A | SE | |
| On/Of
f
Statu
s | Yes | Yes | Yes | -- | -- | SE | |
| Indica
tor
Displ
ay | Low
Batter
y | Yes | Yes | Yes | -- | -- | SE |
| | Volta
ge/Cu
rrent
Level | Yes | Yes | Yes | -- | -- | SE |
| | | | | | | | |
| Timer Range | Yes(
minutes) | 10
None | 20, 40 minutes and
Continuous | -- | -- | SE
Note 2 | |
| Console
weight | 125 g including
battery | 10lbs | 115 g including
battery | -- | -- | SE
Note 3 | |
| Housing
Materials and
Construction | Console: ABS
plastic | Thermoplastic | ABS | Stainless steels 17-
4H,
Rigid ABS | medical grade
biocompatibility
plastics via injection | SE | |
| Elements
of
Comparison | Subject
Device | Predicate
Device | Predicate
Device | Predicate
Device | Predicate
Device | Remark | |
| | | | | | molding | | |
| | Micro current Output Specification | | | | | | |
| Waveform | Pulsed Biphasic | Biphasic | Biphasic | N/A | N/A | SE | |
| Shape | Rectangular | Rectangular | Rectangular | N/A | N/A | SE | |
| Maximum
Output
Voltage
(+/-
10%) | $1.49V @ 500\Omega$
$2.48V @ 2k\Omega$
$10.6V @ 10k\Omega$ | $0.347V @ 500\Omega$
$1.242V @ 2k\Omega$
$5.780V @ 10k\Omega$ | $1.78V @500\Omega$
$6.64V @2k\Omega$
$16.2V @10k\Omega$ | N/A | N/A | SE
Note 4 | |
| Maximum
output
Current | $2.98mA @ 500\Omega$
$1.24mA @ 2k\Omega$
$1.06mA @ 10k\Omega$ | $0.647mA @ 500\Omega$
$0.625mA@ 2k\Omega$
$0.584mA@ 10k\Omega$ | $3.56mA @500\Omega$
$3.32mA @2k\Omega$
$1.62mA @10k\Omega$ | N/A | N/A | SE
Note 4 | |
| Frequency
range | 60Hz | 0.62 1 - 308.6 | 8Hz, 9Hz, 10Hz | N/A | N/A | SE
Note 5 | |
| Pulse
width
range | 4ms | 3.24-1610 ms | -- | N/A | N/A | SE
Note 5 | |
| Pulse
duration | 4ms | 3.24-1610 ms | ~49-63mS | N/A | N/A | SE
Note 5 | |
| Net Charge | $0 \mu C @ 500\Omega$ | $0 uC @500\Omega$ | 19.64 uC | N/A | N/A | SE | |
| Maximum | 0.524mA/cm²@ | 1.486mA/cm²@ | 0.26mA/cm2 | N/A | N/A | SE | |
| Elements
of
Comparison | Subject
Device | Predicate
Device | Predicate
Device | Predicate
Device | Predicate
Device | Re
mark | |
| Current
Density | 500Ω | 500Ω | (8Hz/500Ω) | | | Note 6 | |
| Maximum
Power
Density | 0.216mW/cm²@
500Ω | 0.366 mW/cm² @
500Ω | 1.33mW/cm2
(8Hz/10kΩ) | N/A | N/A | SE | |
| ON time | Constant | 10-30s | Constant | N/A | N/A | SE | |
| OFF time | None | 1-6s | None | N/A | N/A | SE | |
| Contraction
and
Relaxation
time | Adjustable,
due
to
different
modes. | Adjustable, due to
different modes. | -- | N/A | N/A | SE | |
| For LED red light irradiation function | | | | | | | |
| LED
wavelength | Red-light:
630±10nm
Blue
light :415±10nm | -- | -- | 415±15nm | 650 +/- 5nm | SE | |
| LED
Power
Density | Red light:
80 W/cm2
Blue light:
50 W/cm² | -- | -- | 50 W/cm² | 80mW/cm² | SE | |
| Additional Features | | | | | | | |
| Environment | Temperature: 5 | + 50 to 104°
F | | | | SE | |
| Elements
of
Comparison | Subject
Device | Predicate
Device | Predicate
Device | Predicate
Device | Predicate
Device | Remark | |
| for operating | ~ 40° C
Relative
humidity: