(397 days)
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.
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.
The provided text is a 510(k) summary for the "Smart Photon Micro-current Device: EP-300". This document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and safety testing. It does not include acceptance criteria for clinical performance or details of a clinical study to prove the device meets such criteria.
The "Test Summary" section (page 6) lists the tests performed, which are primarily related to safety, electrical compatibility, and software validation, not clinical effectiveness. There is no information about clinical acceptance criteria for aesthetic outcomes (e.g., reduction in periorbital wrinkles, improvement in acne).
Here's an analysis of what information is provided regarding testing and comparison, structured to answer your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria for clinical performance or a table of reported device performance against such criteria. Instead, it compares the subject device's specifications to those of predicate devices and states that safety and performance were evaluated through various engineering and electrical tests. The implicit "acceptance criterion" is to demonstrate substantial equivalence to the predicate devices through technical similarities and compliance with international safety standards.
The table below summarizes the comparative technical specifications and the conclusion of "Substantial Equivalence (SE)" provided in the document. This is not a direct assessment of an "acceptance criterion" for clinical efficacy, but rather a comparison of technical features to establish equivalence for regulatory purposes.
| Elements of Comparison (Acceptance Criteria are inferred technical specifications found in predicate devices or safety standards) | Subject Device Performance (Reported Performance) |
|---|---|
| Device Name and Model | Smart Photon Micro-current Device, Model: EP-300 |
| Product Code | NFO, OHS, OLP |
| Regulation Number | 882.5890, 878.4810 |
| Intended Use (Micro-current mode) | Facial stimulation for over-the-counter aesthetic use. |
| Intended Use (Red light mode) | Treatment of periorbital wrinkles. |
| Intended Use (Blue light mode) | Treatment of mild to moderate acne. |
| Applicable Body Parts | Face |
| Power Sources | 3.7V, 800mAh rechargeable lithium battery (Note 1: Safety/effectiveness comparable to predicate's different power sources) |
| Method of Line Current Isolation | Battery Supply N/A (Note 1: Safety/effectiveness comparable to predicate's different isolation methods) |
| Number of Modes for Micro current stimulation | 1 |
| Number of Channels for Micro current stimulation | 1 |
| Synchronous or Alternating | Alternating |
| Regulated Current or Regulated Voltage | Regulated Voltage |
| Software/Firmware/Microprocessor Control | Yes |
| Automatic Overload Trip | Yes |
| Automatic No-load Trip | Yes. |
| Automatic Shut Off | Yes. |
| Patient Override Control | Yes |
| On/Off Status Indicator | Yes |
| Indicator Display (Low Battery) | Yes |
| Indicator Display (Voltage/Current Level) | Yes |
| Timer Range | Yes (minutes), adjustable (Note 2: Differences in timer range do not affect safety/effectiveness based on intended use and user manual guidance) |
| Console weight | 125 g including battery (Note 3: Minor weight differences comply with IEC60601-1 and do not affect safety/effectiveness) |
| Housing Materials and Construction | Console: ABS plastic |
| Micro current Output Waveform | Pulsed Biphasic, Rectangular shape |
| Maximum Output Voltage (+/- 10%) | 1.49V @ 500Ω, 2.48V @ 2kΩ, 10.6V @ 10kΩ (Note 4: Within range of predicate devices; complies with safety standards) |
| Maximum Output Current | 2.98mA @ 500Ω, 1.24mA @ 2kΩ, 1.06mA @ 10kΩ (Note 4: Within range of predicate devices; complies with safety standards) |
| Frequency range | 60Hz (Note 5: Minor differences comparable to predicate and covered by K130065; complies with safety standards) |
| Pulse width range | 4ms (Note 5: Minor differences comparable to predicate and covered by K130065; complies with safety standards) |
| Pulse duration | 4ms (Note 5: Minor differences comparable to predicate and covered by K130065; complies with safety standards) |
| Net Charge | 0 µC @ 500Ω |
| Maximum Current Density | 0.524mA/cm² @ 500Ω (Note 6: Within range of predicate devices) |
| Maximum Power Density | 0.216mW/cm² @ 500Ω (Note 6: Within range of predicate devices and meets FDA guidance max of 0.25 W/cm²) |
| ON time | Constant |
| OFF time | None |
| Contraction and Relaxation time | Adjustable, due to different modes. |
| Red LED wavelength | 630±10nm (Note 7: Close to predicate; passed IEC62471 and IEC60601-2-57) |
| Blue LED wavelength | 415±10nm (Note 7: Same as predicate; passed IEC62471 and IEC60601-2-57) |
| Red LED Power Density | 80 W/cm2 |
| Blue LED Power Density | 50 W/cm² |
| Operating Environment (Temperature, Humidity) | 5 ~ 40 °C, |
§ 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).