(89 days)
Not Found
No
The device description and performance studies focus on electrical stimulation, red light therapy, and basic software control (on/off, mode switching, timer). There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The software is described as "moderate" concern, which is typical for devices with basic control functions.
Yes.
The device is intended for "treating wrinkles on the face," which is a medical purpose, especially given it is mentioned alongside predicate devices which are likely classified as therapeutic.
No
The device is intended for treating wrinkles and facial/neck stimulation, not for identifying, monitoring, or diagnosing a medical condition.
No
The device description clearly states it is a hand-held, battery-powered device that applies transcutaneous electrical currents and emits red light, indicating it is a hardware device with embedded software. The summary also mentions hardware-related testing (electrical safety, biocompatibility) and software verification/validation, further confirming it is not software-only.
Based on the provided information, the Radiant Renewal Skincare Wand (Models: HD-15, HD-15A) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for treating wrinkles on the face and stimulating the face and neck. This is a direct application to the body for cosmetic and therapeutic purposes.
- Device Description: The device uses transcutaneous electrical currents and red light applied externally to the skin.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
- Anatomical Site: The device is applied to the face and neck, which are external anatomical sites.
- Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, biocompatibility, software validation, and usability. These are typical for devices applied to the body, not for analyzing biological samples.
- Predicate Devices: The listed predicate devices are also skincare or cosmetic devices that apply energy or stimulation to the skin.
In summary, the Radiant Renewal Skincare Wand is a device for external application to the body for cosmetic and therapeutic effects, not for analyzing biological samples in a laboratory setting. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use.
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.
Product codes (comma separated list FDA assigned to the subject device)
OHS, NFO
Device Description
The Radiant Renewal Skincare Wand (Model: HD-15, HD-15A) is a hand-held, battery-powered device used to stimulate the face and neck superficially through application of transcutaneous electrical currents and treat wrinkles by emitting 630 nanometers of red light. The device is powered by a Lithium-lon rechargeable battery, and it has a charging cable, carrying case and instruction manual.
There are two models of the device, with only differences in operating modes. Model HD-15 only has a red-light wrinkle treatment effect, while Model HD-15A has two functional modes: one is red light wrinkle treatment, and the other is micro current stimulation of the face and neck.
Both of them have one button to turn on/off the device. For model HD-15A, this button also can switch the mode.
The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes. After every three minutes of treatment, the device will vibrate the time. If you need to continue treatment, simply turn on the device again.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face, neck
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)
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
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.
K171821, K212342, K163470, K202055
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
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2023
Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Dijkstra Official Correspondent Building#3 and Building#5, 40th of Fuxin Street Huaide Community Fuyong Town, Baoan District Shenzhen, 518103 China
Re: K232863
Trade/Device Name: Radiant Renewal Skincare Wand (HD-15, HD-15A) 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, NFO Dated: August 23, 2023 Received: September 15, 2023
Dear Alain Dijkstra:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang Digitally Digitally signed by Jianting Date: 2023.12.13 13:54:39 -2 -05'00'
For Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232863
Device Name
Radiant Renewal Skincare Wand (HD-15, HD-15A)
Indications for Use (Describe)
The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use.
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over thecounter use.
| 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)
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4
510(k) Summary of K232863
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Establishment Registration Number: 3011644607 Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: requlation@kaiyanmedical.com
Application Correspondent:
Contact Person: Alain Dijkstra Company: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com
2. Subject Device Information:
Trade Name: Radiant Renewal Skincare Wand, model: HD-15, HD-15A Classification Name: Light based OTC for winkle reduction; Transcutaneous Electrical, Aesthetic Purposes Review Panel: General & Plastic Surgery Product Code: OHS, NFO Regulation Number:21 CFR 878.4810, 21 CFR 882.5890 Regulation Class: II
3. Predicate Device Information
Predicate Device 1 (K171821) Sponsor: Heat In A Click Trade Name: 2 Face / Face Evolution (Model: 2 Face / Face Evolution) Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Light Based Over the Counter Wrinkle Reduction, over-the counter powered light based laser for acne Review Panel: General & Plastic Surgery Product Code: NFO, OHS, OLP Regulation Number: 21 CFR 882.5890, 21 CFR 878.4810
Requlation Class: II
Predicate Device 2 (K212342)
Sponsor: ZIIP, Inc. Trade Name: ZIIP+ Device
5
Classification Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief. Review Panel: Neurology Product Code: NFO Regulation Number: 21 CFR 882.5890 Regulation Class: II
Predicate Device 3 (K163470)
Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Trade Name: Galvanic Spa Classification Name: stimulator, transcutaneous electrical, aesthetic purposes Review Panel: Neurology Product Code: NFO Regulation Number: 21 CFR 882.5890 Regulation Class: II
Predicate Device 4 (K202055)
Sponsor: Heat In A Click LLC Trade Name: Looper (Model: ZX-579S) Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over The Counter Wrinkle Reduction (OHS) Review Panel: General & Plastic Surgery Product Code: OLP, OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II
4. Device Description
The Radiant Renewal Skincare Wand (Model: HD-15, HD-15A) is a hand-held, battery-powered device used to stimulate the face and neck superficially through application of transcutaneous electrical currents and treat wrinkles by emitting 630 nanometers of red light. The device is powered by a Lithium-lon rechargeable battery, and it has a charging cable, carrying case and instruction manual.
There are two models of the device, with only differences in operating modes. Model HD-15 only has a red-light wrinkle treatment effect, while Model HD-15A has two functional modes: one is red light wrinkle treatment, and the other is micro current stimulation of the face and neck.
Both of them have one button to turn on/off the device. For model HD-15A, this button also can switch the mode.
The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes. After every three minutes of treatment, the device will vibrate the time. If you need to continue treatment, simply turn on the device again.
5. Intended Use / Indications for Use
The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use.
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.
6. Comparison to predicate devices
Compare with the predicate devices, the subject device is very similar in design principle, intended use,
6
indications for use, functions, material and the applicable standards. The differences between the subject device and predicate devices do not raise new questions of safety or effectiveness.
| Elements of
Comparison | Subject
device | Predicate
device
(K171821) | Predicate
1 device
(K212342) | Predicate
2 device
(K163470) | Predicate
3 device
(K202055) | 4 Remark |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Manufacturer | Shenzhen
Kaiyan
Medical
Equipment
Co., Ltd | Heat In A
Click | ZIIP Inc. | ShenZhen Siken
3D Technology
Development
Co., Ltd. | Heat In A Click
LLC | |
| 510
Number | (K) K232863 | K171821 | K212342 | K163470 | K202055 | |
| Device Name | Radiant
Renewal
Skincare
Wand | 2 Face / Face
Evolution
(Model:
Face / Face
Evolution) | Micro-current
Wrinkle
Reduction
Facial Service | Galvanic Spa,
Model:
SKB-
1405 | Looper | |
| OTC/Rx | OTC | OTC | OTC | OTC | OTC | Same |
| Regulation
Class | Class II | Class II | Class II | Class II | Class II | Same |
| Product Code | NFO, OHS | NFO, OHS,
OLP | NFO | NFO | OHS, OLP | Same |
| Mechanism of
Action | Microcurrent
electrical
therapy to
deliver skin
stimulation;
Red light
treatment for
facial
wrinkles. | Microcurrent
electrical
therapy to
deliver skin
stimulation;
Red light
treatment for
facial wrinkles;
Bule light
treatment for
mild to
moderate
inflammatory
acne. | Microcurrent
electrical
therapy to
deliver skin
stimulation | Microcurrent
electrical therapy
to deliver skin
stimulation | Blue light therapy
for mild to
moderate
inflammatory
acne;
Red light
treatment for
facial wrinkles. | Same |
| Regulation
Number | 21 CFR
882.5890,
21 CFR
878.4810 | 21 CFR
882.5890,
21 CFR 878.4810 | 21 CFR
882.5890 | 21 CFR
882.5890 | 21 CFR
878.4810 | Same |
| Indications for
Use / Intended
use | The Radiant
Renewal
Skincare
Wand
(Model: HD-
15) is
intended for
treating
wrinkles on
the face and | 2 Face / Face
Evolution is a
hand-held
device for
over-the
counter
aesthetic
purposes.
(1) The EMS
mode is
indicated
for | The ZIIP+
Device is
intended for
facial and neck
stimulation and
is indicated for
over-the-
counter use. | The Galvanic
Spa (Model:
SKB-1405) is
intended for
facial stimulation
and is indicated
for over-the
counter cosmetic
use. The
anatomical site | Looper (Model:
ZX-579S) is a
hand-held device
for over-the
counter aesthetic
purposes. The
Photon mode red
light is indicated
for the use in
treating wrinkles
on the face, and | Same |
| Elements of Comparison | Subject device | Predicate device (K171821) | Predicate 1 device (K212342) | Predicate 2 device (K163470) | Predicate 3 device (K202055) | 4 Remark |
| | is indicated for over-the- counter use. The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the- counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the- counter use. | facial stimulation; (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. | | the Galvanic Spa is the face. | the blue light is indicated for the treatment of the mild to moderate inflammatory acne. | |
| Material/ Biocompatibility | PC and Aluminum | ABS Plastic & Stainless Steel | Biocompatible materials typically used in medical devices and identical to predicate ZIIP device | Stainless steel | ABS Plastic & Stainless Steel | & Different , note 1 |
| Power Source | Lithium battery: 3.7V, 500mAh, 1.85Wh | DC 2200mAh | 3.7V Internal Rechargeable Lithium Ion Battery | 3.7V Li-battery | DC 3.7V 1000mA Li battery | Different , note 2 |
| Sterility | Not applicable – this device is not sold sterile | Not applicable – this device is not sold sterile | Not applicable – this device is not sold sterile | Not applicable – this device is not sold sterile | Not applicable – this device is not sold sterile | Same |
| Human Factors | Hand-held device | Hand-held device | Hand-held device | Hand-held device | Hand-held device | Same |
| Electrical Safety | Compliant with | Compliant with | Compliant with IEC 60601-1 | Compliant with IEC 60601-1 | Compliant with IEC 60601-1 | Same |
| Elements of
Comparison | Subject
device | Predicate
device 1
(K171821) | Predicate
device
(K212342) | Predicate
2 device
(K163470) | Predicate
3 device
(K202055) | 4 Remark |
| | 60601-1,
IEC 60601-1-2,
IEC 60601-1-11,
IEC 62471,
IEC 60601-2-10,
IEC 60601-2-57 | 60601-1,
IEC 60601-1-2,
IEC 62471,
IEC 60601-2-57 | IEC 60601-1-2,
IEC 60601-1-11 | IEC 60601-1-2,
IEC 60601-2-10 | 60601-1-2,
60601-1-11,
62471,
60601-2-57 | IEC |
| Type of
Energy | LED,
Electrical
current | LED,
Electrical
current | Electrical
current | Electrical
current | LED | Same |
| Charging
Method | External wall
adaptor | External wall
adaptor | External wall
adaptor | External wall
adaptor | No publicity | Same |
| Detailed Output Characteristics | | | | | | |
| Power
Source(s) | -- | -- | -- | -- | -- | -- |
| a) Method of
Line Current
Isolation | One
rechargeable
Lithium-Ion
Battery and
External
Charger
Isolation | One
rechargeable
Lithium-Ion
Battery and
External
Charger
Isolation | One
rechargeable
Lithium-Ion
Battery and
External
Charger
Isolation | One
rechargeable
Lithium-Ion
Battery and
External Charger
Isolation | Type BF | Same |
| b) Patient
Leakage
Current | -- | -- | External
Charger
Included | -- | No publicity | -- |
| - Normal
Condition | ≤100μΑ | No publicity | 46 μΑ | No publicity | No publicity | Different
, note 2 |
| - Fault
Condition | ≤500μΑ | No publicity | 46 μΑ | No publicity | No publicity | Different
, note 2 |
| Number of
Output
Modules | 1 | 2 | 1 | 1 | Not applicable | Same |
| Number of
Output
Channels | 1 | 2 | 1 | 1 | Not applicable | Same |
| a)
Synchronous
or Alternating | N/A – 1
Output
Channel | No publicity | N/A – 1 Output
Channel | Alternating | Not applicable | Same |
| b) Method of
Channel
Isolation | N/A – 1
Output
Channel | Type BF | N/A - 1 Output
Channel | No publicity | Not applicable | Same |
| Regulated
Current or
Regulated
Voltage | Both | Both | Both | Both | Not applicable | Same |
| Software/ | Yes | Yes | Yes | Yes | Yes | Same |
| Elements
of Comparison | Subject
device | Predicate
device
(K171821) | Predicate
device
(K212342) | Predicate
device
(K163470) | Predicate
device
(K202055) | Remark |
| Firmware/
Microprocessor
Controlled | | | | | | |
| Automatic
Overload Trip | Yes | No | Not required
because of
circuit design
(Current and
Voltage
Limited by
Circuit Design
and Firmware) | Yes | Not applicable | Same |
| Automatic No-
Load Trip | No | Yes | Yes
(Reversion to
Fixed Voltage
Output) | Yes | Not applicable | Different,
note 2 |
| Automatic
Shut Off | Yes | Yes | Yes | Yes | Yes | Same |
| Patient
Override
Control | Yes | Yes | Yes | Yes | Yes | Same |
| Indicator Display | | | | | | |
| a)
On/Off
Status | Yes | Yes | Yes
(LED
Illumination on
Conduction) | Yes | Yes | Same |
| b) Low Battery | Yes | Yes | Yes | No | Yes | Same |
| c)
Voltage/Current
Level | Yes | Yes | Yes
(LED
Illumination on
Target Current
Levels) | Yes | Yes | Same |
| Output Specifications | | | | | | |
| Waveform | Pulsed
Biphasic | Pulsed
Biphasic,
Modulated
Square | Pulsed
Biphasic | Pulsed Biphasic | Not applicable | Same |
| Shape | Rectangular | Rectangular | Modulated
Square Wave | Symmetric
biphasic,
rectangular | Not applicable | Same |
| Maximum
Output Voltage | $164 mV @ 500Ω$
$540 mV @ 2kΩ$
$2.28V @ 10kΩ$ | $310mV @ 500Ω$
$1.16V @ 2kΩ$
$5.56V @ 10kΩ$ | $154 mV @ 500Ω$
$465 mV @ 2kΩ$
$2.2 V @ 10kΩ$ | $156mV @ 500Ω$
$0.78V @ 2kΩ$
$2.6V @ 10kΩ$ | Not applicable | Similar,
note 3 |
| Maximum
Current
Density | $328 μA @ 500Ω$
$270 μA @ 2kΩ$ | $620μA @ 500Ω$
$580μA @ 2kΩ$ | $309 μA @ 500Ω$
$232 μA @ 2kΩ$ | $0.31mA @ 500Ω$
$0.39mA @ 2kΩ$
$0.26mA @ 10kΩ$ | Not applicable | Similar,
note 3 |
| Elements of Comparison | Subject device | Predicate device (K171821) | Predicate 1 device (K212342) | Predicate 2 device (K163470) | Predicate 3 device (K202055) | 4 Remark |
| | 228 μA @ 10kΩ | 10kΩ | 10kΩ | | | |
| Frequency range | 10.5Hz | 8.333Hz | No publicity | 9.09 Hz±10 % | Not applicable | Similar, note 3 |
| Pulse duration | 48ms±10% | 60ms | No publicity | 55 ms | Not applicable | Similar, note 3 |
| Maximum Phase Charge | 15.74 μC@ 500Ω | 26.31μC @ 500Ω | 6.16 μC@ 500Ω | 17.1 μC @ 500Ω | Not applicable | Similar, note 3 |
| Maximum Current Density | 0.10 mA/cm²@ 500Ω | 0.330mA/cm² @500Ω | 0.34 mA/cm²@ 500Ω | 0.274mA/cm²@50Ω (The Electrode Size: 1.13 cm²) | Not applicable | Similar, note 3 |
| Maximum Power Density | 0.004 mW/cm²@ 500Ω | 4.34μW/cm² @500Ω | 3.44 W/ cm²@ 500Ω | 42.5μW/cm²@50Ω (The Electrode Size:1.13cm²) | Not applicable | Similar, note 3 |
| ON time | Constant | Constant | Constant | Adjustable, due to different levels | Not applicable | Same |
| OFF time | None | None | None | Adjustable, due to different levels | Not applicable | Same |
| Burst Mode (i.e. pulse trains) | N/A - no burst mode | No publicity | N/A - no burst mode | No publicity | Not applicable | Same |
| LED output Specification | | | | | | |
| LED wavelength | Red: 630nm ± 10nm | Red: 630 ± 3nm, Blue: 415 ± 3nm | Not applicable | Not applicable | Red: 630 ± 10nm, Blue: 415 ± 10nm | Same |
| Irradiances | 55mW/cm² ± 10% | Red light: 73.26mw/cm² ± 10% Blue: 64.10mw/cm² ± 10% | Not applicable | Not applicable | Red light: 55mw/cm² ± 10% Blue: 65mw/cm² | Similar, note 4 |
| LED output Specification | | | | | | |
| Environment for operating | Temperature: 0-30°C Humidity: 30-95% Atmospheric Pressure: 700hPa-1060hPa | No publicity | Temperature: 5 ~ 40° C | Temperature: 5°C~40°C Humidity: ≤80 % | Temperature: 0-30°C Humidity: 30-95% Atmospheric Pressure: 700hPa-1060hPa | Different, note 2 |
| Environment for storage | Temperature: -5-55 °C Humidity: | No publicity | Temperature: 25 70° C Humidity: | Temperature:0 45°C Humidity: