Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)
Device Facts
| Record ID | K260767 |
|---|---|
| Device Name | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) |
| Applicant | Kam Yuen Plastic Products , Ltd. |
| Product Code | OHS · General, Plastic Surgery |
| Decision Date | Aug 31, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Facial Mask LED Beauty Device A-901 is an over-the-counter device. The Red light mode is intended for the treatment of full face wrinkles. The Red and Infrared light combination mode is intended for the treatment of full-face wrinkles. The blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only. Facial LED & EMS Beauty Device A-902 is an over-the-counter device. The Red light mode is intended for the treatment of facial wrinkles. The EMS mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only. Facial Mask LED & EMS Beauty Device A-907 is an over-the-counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The EMS mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only. The devices are intended for use on Fitzpatrick skin types I, II, and III.
Device Story
Facial Beauty Device (models A-901, A-902, A-907) comprises LED-based masks for home use; operated by adults. Inputs: user-selected light modes (Blue, Red, Near-Infrared) and EMS (Electrical Muscle Stimulation) current. Operation: LEDs emit specific wavelengths (415-830nm) for skin therapy; electrodes deliver pulsed, biphasic, rectangular microcurrent for facial stimulation. A-902/A-907 include infrared remote controllers. Output: light irradiation and electrical stimulation to facial skin. Benefits: wrinkle reduction, acne treatment, facial stimulation. Safety: 10-minute automatic shut-off; requires user-provided protective eyewear (OD ≥ 6.0).
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-5, -10, -23) and electrical/photobiological safety (IEC 60601-1, -1-2, -1-11, -2-10, -2-57, and IEC 62471).
Technological Characteristics
Materials: ABS, PC plastic, silicone, stainless steel. Energy: Li-Ion battery-powered, AC adapter. Light: LED-based (415-850nm). EMS: Pulsed, symmetric biphasic, rectangular waveform. Connectivity: Infrared remote control (A-902, A-907). Standards: IEC 60601-1, IEC 60601-2-57, IEC 62471, ISO 10993. Software: Embedded firmware with automatic 10-minute shut-off and overload protection.
Indications for Use
Indicated for adults with Fitzpatrick skin types I-III for the treatment of facial/periorbital wrinkles, facial stimulation (EMS models), and mild to moderate inflammatory acne.
Regulatory Classification
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.
Predicate Devices
- TheraFace Mask (K230293)
- LED Facial Mask MZ-01, NEWKEY-01, SP-FM-01 (K230351)
- LunaTM 4 plus (K241102)
- Micro-current Facial Beauty Device AM-810W, AM-810B, AM-812W, AM-812B (K243430)
Reference Devices
- SonicLift Model: ST261 (K150077)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG
ADMINISTRATION
August 31, 2026
Kam Yuen Plastic Products, Ltd.
% Jett Lee
Regulation Manager
Guangdong Jianda Medical Technology Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Guangzhou, / 510663
China
Re: K260767
Trade/Device Name: Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)
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, OLP, NFO, IRO
Dated: August 3, 2026
Received: August 3, 2026
Dear Jett Lee:
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
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
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(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-devices/device-advice-comprehensive-regulatory-assistance/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,
TANISHA L. HITHE -S
Digitally signed by
TANISHA L. HITHE -S
Date: 2026.08.31
21:31:30 -04'00'
Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K260767
Device Name
Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)
Indications for Use (Describe)
Facial Mask LED Beauty Device A-901 is an over-the-counter device. The Red light mode is intended for the treatment of full face wrinkles. The Red and Infrared light combination mode is intended for the treatment of full-face wrinkles. The blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
Facial LED & EMS Beauty Device A-902 is an over-the-counter device. The Red light mode is intended for the treatment of facial wrinkles. The EMS mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
Facial Mask LED & EMS Beauty Device A-907 is an over-the-counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The EMS mode is intended for facial stimulation.
The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
The devices are intended for use on Fitzpatrick skin types I, II, and III.
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)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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"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."
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**Date of the summary prepared: August 25, 2026**
## **510(k) Summary of K260767**
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
### **1 Submitter Information**
Sponsor: Kam Yuen Plastic Products Ltd.
Establishment Registration Number: 10078856
Address: No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town, ZhongShan,
Guangdong, China
Phone: 86- 400- 962- 1668
Fax: 86- 0760- 8841- 3080
Contact Person: Shihe Wu
E-mail: kamyuen@kyplastic.com
Application Correspondent: Jett Lee
Company: Guangdong Jianda Medical Technology Co., Ltd
E-mail: jianda-lee@foxmail.com
Phone: 86-13512755282
Address: 906 Room, Longxiang Garden, Tianhe district, Guangzhou, China
### **2 Subject Device Information**
Type of 510(k) submission: Traditional
Common or Usual Name: Light Based Over the Counter Wrinkle Reduction / Over-the-
Counter Powered Light Based Laser for Acne / Stimulator, Transcutaneous Electrical,
Aesthetic Purposes / Vibratior, Therapeutic
Trade Name: Facial Beauty Device
Model: Facial Mask LED Beauty Device A-901, Facial LED & EMS Beauty Device
A-902, Facial Mask LED & EMS Beauty Device A-907
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Review Panel: General & Plastic Surgery / Neurology
Product Code: OHS, OLP, NFO, IRO
Regulation Name: Laser surgical instrument for use in general and plastic surgery
and in dermatology / Transcutaneous Electrical Nerve Stimulator For Pain Relief /
Therapeutic vibrator
Regulation Number: 21 CFR 878.4810 / 882.5890 / 890.5975
Regulation Class: 2
### 3 Predicate Device Information
For Facial Mask LED Beauty Device A-901
| Device Name and model | TheraFace Mask | LED Facial MaskMZ-01, NEWKEY-01, SP- FM-01 |
| --- | --- | --- |
| 510K No. | K230293 | K230351 |
| Regulation No. | 878.4810 | 878.4810 |
| Regulation class | Class 2 | Class 2 |
| Product code | OHS, OLP | OHS, OLP |
For Facial LED & EMS Beauty Device A-902
| Device Name and model | LED Facial MaskMZ-01, NEWKEY-01, SP-FM-01 | LunaTM 4 plus | Micro-current Facial Beauty DeviceAM-810W, AM-810B, AM-812W, AM-812B | SonicLiftModel: ST261(Reference device) |
| --- | --- | --- | --- | --- |
| 510K No. | K230351 | K241102 | K243430 | K150077 |
| Regulation No. | 878.4810 | 878.4810,882.5890 | 882.5890 | 882.5890890.5975 |
| Regulation class | Class 2 | Class 2 | Class 2 | Class 2 |
| Product code | OHS, OLP | OHS, NFO | NFO | NFO, IRO |
For Facial Mask LED & EMS Beauty Device A-907
| Device Name and model | LED Facial MaskMZ-01, NEWKEY-01, SP- | LunaTM 4 plus | Micro-current Facial Beauty Device |
| --- | --- | --- | --- |
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| | FM-01 | | AM-810W, AM-810B, AM-812W, AM-812B |
| --- | --- | --- | --- |
| 510K No. | K230351 | K241102 | K243430 |
| Regulation No. | 878.4810 | 878.4810, 882.5890 | 882.5890 |
| Regulation class | Class 2 | Class 2 | Class 2 |
| Product code | OHS, OLP | OHS, NFO | NFO |
#### 4 Device Description
Facial Beauty Device includes three models—Facial Mask LED Beauty Device A-901, Facial LED & EMS Beauty Device A-902, and Facial Mask LED & EMS Beauty Device A-907. These devices are intended to improve the appearance of full-face wrinkles, periorbital wrinkles, facial wrinkles, and mild to moderate inflammatory acne using LED light therapy and EMS (Electrical Muscle Stimulation) technology. The devices are intended for use on Fitzpatrick skin types I, II, and III.
# 1) Facial Mask LED Beauty Device A-901
Facial Mask LED Beauty Device A-901 consists of a full-face shape mask, a controller with battery and an AC power adapter, which directly applies light onto the face skin surface and makes use of specific light spectral characteristics. The device has LEDs distributed on the mask and it can operated in three operation modes: Blue light, Red light and Red combined with Near infrared light, which can emit Blue (415±10 nm) light, Red (630±10 nm) light or Red + NIR (near infrared, 830±10 nm) light. The Red light is intended for the treatment of full face wrinkles. The Red and NIR light is intended for the treatment of full-face wrinkles. The Blue light is intended for the treatment of the mild to moderate inflammatory acne. Each mode can shutdown in 10 minutes automatically.
# 2) Facial LED & EMS Beauty Device A-902
Facial LED & EMS Beauty Device A-902 consists of a V-shaped mask with elastic belt, an infrared remote with battery, and an AC power adapter, which directly applies light and microcurrent electrical stimulation current onto the facial skin surface and makes use of specific light spectral characteristics or microcurrent electrical stimulation current. By
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adjusting the position of the mask and belt, the device can be applied to different positions of the face. The device designed with four operation modes: Red light, Blue light, Microcurrent electrical stimulation and Vibration mode. It has LEDs distributed on the mask which can emit Blue (460±10 nm) light, Red (620±10 nm) light. In the Microcurrent electrical stimulation mode, the device can output microcurrent electrical stimulation current to the facial skin via the electrodes in the mask. The Red light mode is intended for the treatment of facial wrinkles. The Microcurrent electrical stimulation mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The Vibration mode is intended to provide soothing relaxation with continuous gentle vibrations. Each mode can shutdown in 10 minutes automatically.
The Vibration function has no medical purpose and operates independently which does not alter the device's intended medical use.
# 3) Facial Mask LED & EMS Beauty Device A-907
Facial Mask LED & EMS Beauty Device A-907 consists of a half face shape mask, an infrared remote with battery, a mask holder and an AC power adapter, which directly applies light and microcurrent electrical stimulation current onto the face skin surface and makes use of specific light spectral characteristics or microcurrent electrical stimulation current. The device designed with three operation modes: Red light, Blue light and Microcurrent electrical stimulation mode. It has LEDs distributed on the mask which can emit Blue (460±10 nm) light, Red (620±10 nm) light. In the Microcurrent electrical stimulation mode, the device can output microcurrent electrical stimulation current to the facial skin via the electrodes in the mask. The Red light mode is intended for the treatment of periorbital wrinkles. The Microcurrent electrical stimulation mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. Each mode can shutdown in 10 minutes automatically.
# Remote controller:
For the remote of A-902 and A-907, the device operation can be controlled by controller via infrared light. It does not include any patient data. Infrared remote controls use infrared (IR) light to convey information. The infrared light is emitted from an IR LED controlled by the modulated signal from the transmitter's MCU. Modulation can help the receiver distinguish
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the desired signals from other infrared noise sources. And the remote controlling operation distance is very short. So, no any cybersecurity issue may caused by such the remote controlling communication.
# Eye Safety and Required Protective Eyewear
This device emits optical radiation that may pose a hazard to the user's eyes during operation. The device is not supplied with protective eyewear. Users must provide their own professional protective eyewear that meets the following minimum optical specifications prior to operating the device:
- Wavelength coverage: 400 nm - 850 nm
- Optical density (OD): ≥ 6.0
# 5 Intended Use / Indications for Use
1) Facial Mask LED Beauty Device A-901
Facial Mask LED Beauty Device A-901 is an over-the-counter device. The Red light mode is intended for the treatment of full face wrinkles. The Red and Infrared light combination mode is intended for the treatment of full-face wrinkles. The blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
2) Facial LED & EMS Beauty Device A-902
Facial LED & EMS Beauty Device A-902 is an over-the-counter device. The Red light mode is intended for the treatment of facial wrinkles. The Microcurrent electrical stimulation mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
3) Facial Mask LED & EMS Beauty Device A-907
Facial Mask LED & EMS Beauty Device A-907 is an over-the-counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The Microcurrent electrical stimulation mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.
The devices are intended for use on Fitzpatrick skin types I, II, and III.
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# 6 Comparison to predicate device and conclusion
6.1 SE comparison of Facial Mask LED Beauty Device A-901
| Features | Subject Device | Predicate Device K230293 | Predicate Device K230351 |
| --- | --- | --- | --- |
| Regulation Information | | | |
| Device Name and Model | Facial Beauty Device Facial Mask LED Beauty Device A-901 | TheraFace Mask | LED Facial Mask MZ-01, NEWKEY-01, SP- FM-01 |
| 510(k) Number | Applying | K230293 | K230351 |
| Regulation number | 878.4810 | 878.4810 | 878.4810 |
| Classification | Class 2 | Class 2 | Class 2 |
| Product code | OHS, OLP | OHS, OLP | OHS, OLP |
| Intended Use | Facial Mask LED Beauty Device A-901 is an over-the-counter device. The Red light mode is intended for the treatment of full face wrinkles. The Red and Infrared light combination mode is intended for the treatment of full-face wrinkles. The blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only. | ●Red Light is intended to treat full face wrinkles ●Blue Light is intended to treat mild to moderate inflammatory acne ●Red + Infrared Light is intended to treat full face wrinkles | LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne. |
| Indications for Use | OTC | OTC | OTC |
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| Performance Comparison | | | |
| --- | --- | --- | --- |
| Location for use | Face | Face | Face |
| Treatment time | 10 minutes / day, 3-4 days per week | LED: 3 minutes each light mode for a total of 9 minutes per treatment, recommended to use 2 to 5 times per week. | 10 minutes/day, 3 times per week |
| Power supply | External battery charger Input: 100-240V AC, 50/60 Hz Output: 5.0V DC powered by Li-Ion Batteries (3.7V 1500mAh) | 5-15V DC 2.5A max powered by 2 Li-Ion Batteries 3.7V 1500mAh) is charged via Universal USB charger cord or fast charger adaptor | An external adapter Input: AC 100-240V, 50-60Hz 0.2A Output: DC 12V 0.5A |
| Software control | YES | YES | Unknown |
| Irradiance source | LED Light emitting diodes (LEDs) | Light emitting diodes (LEDs) | Light emitting diodes (LEDs) |
| Wavelength | Blue light: 460±10 nm Red light: 620±10 nm NIR(Infrared) light: 850±10 nm | Red: 633±10nm Blue: 415±10nm Red+IR:633nm±10nm/830±10 nm | Blue: 465nm±5nm Red: 625nm±5nm Amber: 605nm±5nm |
| Irradiance (mW/cm²) | Blue: 60.7mW/cm² Red: 66.5mW/cm² Red+IR: 66.5mW/cm² / 52.5mW/cm² | Red: 73±5mW/cm² Blue: 64±5mW/cm² Red+IR: 73±5mW/cm² / 55±5mW/cm² | Blue: 15~63mW/cm² Red: 31~75mW/cm² |
| Main Materials | ABS, Silicone | ABS and PC plastic | ABS and PC plastic |
| Safety Comparison | | | |
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| Electrical Safety | IEC 60601-1 | IEC 60601-1 | IEC60601-1-2 |
| --- | --- | --- | --- |
| | IEC 60601-1-2 | IEC 60601-1-2 | IEC60601-1 |
| | IEC 60601-1-11 | IEC 60601-1-11 | IEC60601-1-11 |
| | IEC 60601-2-57 | IEC 60601-2-57 | IEC60601-2-57 |
| | IEC 62471 | IEC 62471 | IEC 62471 |
| Biocompatibility | ISO 10993-5 | ISO 10993-5 | Comply with |
| | ISO 10993-10 | ISO 10993-10 | ISO10993-1, ISO10993-5 and |
| | ISO 10993-23 | ISO 10993-23 | ISO10993-10 |
The technological characteristics, features, specifications, materials, and intended use of Facial Beauty Device (Facial Mask LED Beauty Device A-901) 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.
## 6.2 SE comparison of Facial LED & EMS Beauty Device A-902
| Features | Subject Device | Predicate Device K241102 | Predicate Device K243430 | Predicate Device K230351 | Reference Device K150077 |
| --- | --- | --- | --- | --- | --- |
| **Regulation Information** | | | | | |
| Device Name and Model | Facial Beauty Device Facial LED & EMS Beauty Device A- | Luna™ 4 plus | Micro-current Facial Beauty Device AM-810W, AM-810B, AM- 812W, AM-812B | LED Facial Mask MZ-01, NEWKEY-01, SP- FM-01 | SonicLift Model: ST261 |
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| | 902 | | | | |
| --- | --- | --- | --- | --- | --- |
| 510(k) Number | Applying | K241102 | K243430 | K230351 | K150077 |
| Regulation number | 878.4810 882.5890 890.5975 | 878.4810 882.5890 | 882.5890 | 878.4810 | 882.5890 890.5975 |
| Classification | Class 2 | Class 2 | Class 2 | Class 2 | Class 2 |
| Product code | OHS, OLP, NFO, IRO | OHS, NFO | NFO | OHS, OLP | NFO, IRO |
| Intended Use | Facial LED & EMS Beauty Device A- 902 is an over-the- counter device. The Red light mode is intended for the treatment of facial wrinkles. The Microcurrent | Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage. Microcurrent: indicated for facial | Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation. | LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne. | This device is intended for facial stimulation and is indicated for over-the- counter cosmetic use. |
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| | electrical stimulation mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only. | stimulation RED+NIR: indicated to treat periorbital wrinkles | | | |
| --- | --- | --- | --- | --- | --- |
| Indications for Use | OTC | OTC | OTC | OTC | OTC |
| **Device Characteristics** | | | | | |
| Location for use | Face | Face | Face and neck | Face | Face |
| Treatment time | 10 minutes / day, 3-4 days per week | Yes (1-4 min) (adjustable) | MS-Micro current stimulation mode: It is recommended to use the product 10-15 minutes at a | 10 minutes/day, 3 times per week | Unknown |
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| | | | time / 2-3 times a week. | | |
| --- | --- | --- | --- | --- | --- |
| Power supply | External battery charger Input: 100-240V AC, 50/60 Hz Output: 5.0V DC powered by Li-Ion Batteries (3.7V 600mAh) | Internal rechargeable Lithium battery | Adapter input: 5V 0.5A Internal battery: 3.7V/600mAh Rechargeable lithium battery | An external adapter Input: AC 100-240V, 50-60Hz 0.2A Output: DC 12V 0.5A | 3.7V Li-battery |
| Software/Firmware Control | YES | Yes | Yes | Unknown | Yes |
| Automatic Overload Trip | Yes | Not required due to circuit design | Unknown | Unknown | No |
| Automatic Shut off | Yes | Yes | Unknown | Unknown | No |
| **For Micro current facial stimulation function** | | | | | |
| Waveform shape | Pulsed, symmetric biphasic, rectangular | Modulated square | Biphasic pulsed square wave | N/A | Pulsed Biphasic Rectangular |
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| Maximum Output Voltage | 285mV @500Ω 935mV @2kΩ 3.85V@10kΩ | 0.28V @500Ω 1.11V @2KΩ 5.50V @10KΩ | 225mV @ 500Ω 900mV @ 2kΩ 3.60V @ 10kΩ | N/A | 156mV @ 500Ω 780mV @ 2kΩ 2.60V @ 10kΩ |
| --- | --- | --- | --- | --- | --- |
| Maximum Output Current | 570μA @500Ω 467μA @2kΩ 385μA @10kΩ | 560μA @500Ω 555μA @2KΩ 552μA @10KΩ | 450μA @500Ω 450μA @2KΩ 360μA @10KΩ | N/A | 310μA @500Ω 390μA @2KΩ 260μA @10KΩ |
| Pulse width range | 4.2 ms | 290 μs | 4ms | N/A | 112ms |
| Frequency Range | 60Hz | 46Hz | 57Hz | N/A | 8.93Hz |
| Net Charge | 0 μC @ 500Ω | 0 μC(charge - balanced) | 0 μC @ 500Ω | N/A | 0 mC @ 500Ω |
| Maximum Current Density (Electrode Size: 2.5cm²) | 0.164 mA/cm² @500 Ω | 1.37 mA/cm² @500 Ω | AM-810B, AM-810W: 0.10mA/cm²@500 Ω AM-812B, AM-812W: 0.06mA/cm²@500 Ω | N/A | 0.0194 mA/cm² @500 Ω |
| Maximum Power Density (Electrode Size: 2.5cm²) | 0.034 mW/cm² @500 Ω | 0.38 mW/cm² @500 Ω | AM-810B, AM-810W: 0.0117mW/cm²@500 Ω AM-812B, AM-812W: 0.0072mW/cm²@500 Ω | N/A | 0.003 mW/cm² @500 Ω |
| Total Energy per Treatment Session | 50.4 mJ | 37.6 mJ | 91.1 mJ | / | / |
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| For LED red light irradiation function | | | | | |
| --- | --- | --- | --- | --- | --- |
| Irradiance source | LED Light emitting diodes (LEDs) | LED Light emitting diodes (LEDs) | LED Light emitting diodes (LEDs) | Light emitting diodes (LEDs) | / |
| Wavelength | Blue light: 460±10 nm Red light: 620±10 nm | RED light:633nm±10nm Red+IR: 633±10nm / 850nm±10nm | Blue light: 415±10 nm Red light: 630±10 nm | Blue: 465nm±5nm Red: 625nm±5nm Amber: 605nm±5nm | / |
| Irradiance (mW/cm²) | Blue: 60.7mW/cm² Red: 66.5mW/cm² | RED+IR:63 mW/cm² | Blue: 50mW/cm² Red: 80mW/cm² | Blue: 15~63mW/cm² Red: 31~75mW/cm² | / |
| Additional Features | | | | | |
| Weight | 200g | 150g | AM-810B, AM-810W: 118g AM-812B, AM-812W: 130g | Unknown | Main unit: 248g Charge station: 200g Charger Adapter: 180g |
| Dimensions (mm) | 188*52*260 | 82*38*102 | AM-810B, AM-810W: 135*85*39mm AM-812B, AM-812W: 110*92*68mm | Unknown | 3.7' L x 7.6' W x 2.8' D |
| Main Materials | ABS /PC plastic, | Body-safe silicone, | ABS, PC | Unknown | ABS plastic |
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| | Silicone, Stainless steel | ABS plastic, copper, glass, gold, zinc alloy | | | |
| --- | --- | --- | --- | --- | --- |
| User interface | Power button ON/OFF Remote Control: LCD Screen Intensity +/- button Mode Switch button | Power button on/Off Deep cleansing mode button Regular cleansing mode button | Unknown | Unknown | Unknown |
| Environment for operating | Temperature: +10°C~+35°C Relative humidity: 3%~75% RH Pressure: 70 Kpa~106 KPa | Temperature: 5 ~ 40°C Relative humidity:40% ~ 80% | Unknown | Unknown | Temperature: 5 ~ 40°C Humidity: 80% RH |
| Environment for storage | Temperature: -40°C~+70°C Relative humidity: 10%~95% RH Pressure: 50 Kpa~106 KPa | Temperature: -10 ~ 50°C Relative humidity: 30%~ 80% | Unknown | Unknown | Temperature: 5 ~ 40°C Humidity: 80% RH |
| **Safety Information** | | | | | |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC60601-1-2 | IEC 60601-1 |
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| | IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-10 IEC 60601-2-57 IEC 62471 | IEC 60601-1-2 IEC 60601-2-10 IEC 62471 | IEC 60601-1-2 IEC 60601-2-10 IEC 62471 | IEC60601-1 IEC60601-1-11 IEC60601-2-57 IEC 62471 | IEC 60601-1-2 IEC 60601-2-10 |
| --- | --- | --- | --- | --- | --- |
| Biocompatibility | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | Comply with ISO10993-1, ISO10993-5 and ISO10993-10 | ISO 10993-5 ISO 10993-10 |
The technological characteristics, features, specifications, materials, and intended use of Facial Beauty Device (Facial LED & EMS Beauty Device A-902) 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.
As the subject device (A-902) has a vibration function for facial relaxation, which is substantially equivalent to SonicLift, Model: ST261 (K150077).
The classification product code of the subject device is OHS/OLP/NFO while the subsequent product code for the vibration function is IRO (510(k)-exempt).
Therefore, K241102 / K243430 / K230351 are regarded as the main predicate devices, and K150077 is selected to be the reference device for the vibration function.
| Features | Subject Device | Predicate Device K241102 | Predicate Device K243430 | Predicate Device K230351 |
| --- | --- | --- | --- | --- |
| Regulation Information | | | | |
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| Device Name and Model | Facial Beauty Device Facial Mask LED & EMS Beauty Device A-907 | Luna™ 4 plus | Micro-current Facial Beauty Device AM-810W, AM-810B, AM-812W, AM-812B | LED Facial Mask MZ-01, NEWKEY-01, SP- FM-01 |
| --- | --- | --- | --- | --- |
| 510(k) Number | Applying | K241102 | K243430 | K230351 |
| Regulation number | 878.4810 882.5890 | 878.4810, 882.5890 | 882.5890 | 878.4810 |
| Classification | Class 2 | Class 2 | Class 2 | Class 2 |
| Product code | OHS, OLP, NFO | OHS, NFO | NFO | OHS, OLP |
| Intended Use | Facial Mask LED & EMS Beauty Device A-907 is an over-the-counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The Microcurrent electrical stimulation mode is intended for facial stimulation. The Blue light mode is | Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage. Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles | Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation. | LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne. |
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| | intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only. | | | |
| --- | --- | --- | --- | --- |
| Indications for Use | OTC | OTC | OTC | OTC |
| **Device Characteristics** | | | | |
| Location for use | Periorbital | Face | Face and neck | Face |
| Treatment time | 10 minutes / day, 3-4 days per week | Yes (1-4 min) (adjustable) | MS-Micro current stimulation mode: It is recommended to use the product 10-15 minutes at a time / 2-3 times a week. | 10 minutes/day, 3 times per week |
| Power supply | External battery charger Input: 100-240V AC, 50/60 Hz Output: 5.0V DC powered by Li-Ion Batteries (3.7V 1000mAh) | Internal rechargeable Lithium battery | Adapter input: 5V 0.5A Internal battery: 3.7V/600mAh Rechargeable lithium battery | An external adapter Input: AC 100-240V, 50-60Hz 0.2A Output: DC 12V 0.5A |
| Software/Firmware Control | YES | Yes | Yes | Unknown |
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| Automatic Overload Trip | Yes | Not required due to circuit design | Unknown | Unknown |
| --- | --- | --- | --- | --- |
| Automatic Shut off | Yes | Yes | Unknown | Unknown |
| For Micro current facial stimulation function | | | | |
| Waveform shape | Pulsed, symmetric biphasic, rectangular | Modulated square | Biphasic pulsed square wave | N/A |
| Maximum Output Voltage | 280mV @500Ω 900mV @2kΩ 3.60V@10kΩ | 0.28V @500Ω 1.11V @2KΩ 5.50V @10KΩ | 225mV @ 500Ω 900mV @ 2kΩ 3.60V @ 10kΩ | N/A |
| Maximum Output Current | 560μA @500Ω 450μA @2kΩ 360μA @10kΩ | 560μA @500Ω 555μA @2KΩ 552μA @10KΩ | 450μA @500Ω 450μA @2KΩ 360μA @10KΩ | N/A |
| Pulse width range | 4.2 ms | 290 μs | 4ms | N/A |
| Frequency Range | 60 Hz | 46Hz | 57Hz | N/A |
| Net Charge | 0 μC @ 500Ω | 0 μC(charge -balanced) | 0 μC @ 500Ω | N/A |
| Maximum Current Density (Electrode Size: 6cm²) | 0.067 mA/cm² @500 Ω | 1.37 mA/cm² @500 Ω | AM-810B, AM-810W: 0.10mA/cm2@500 Ω AM-812B, AM-812W: 0.06mA/cm2@500 Ω | N/A |
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| Maximum Power Density (Electrode Size: 6cm²) | 0.013 mW/cm² @500 Ω | 0.38 mW/cm² @500 Ω | AM-810B, AM-810W: 0.0117mW/cm²@500 Ω AM-812B, AM-812W: 0.0072mW/cm²@500 Ω | N/A |
| --- | --- | --- | --- | --- |
| Total Energy per Treatment Session | 48.0 mJ | 37.6 mJ | 91.1 mJ | / |
| **For LED red light irradiation function** | | | | |
| Irradiance source | LED Light emitting diodes (LEDs) | LED Light emitting diodes (LEDs) | LED Light emitting diodes (LEDs) | Light emitting diodes (LEDs) |
| Wavelength | Blue light: 460±10 nm Red light: 620±10 nm | RED light:633nm±10nm Red+IR: 633±10nm / 850nm ±10nm | Blue light: 415±10 nm Red light: 630±10 nm | Blue: 465nm±5nm Red: 625nm±5nm Amber: 605nm±5nm |
| Irradiance (mW/cm²) | Blue: 60.7mW/cm² Red: 66.5mW/cm² | RED+IR:63 mW/cm² | Blue: 50mW/cm² Red: 80mW/cm² | Blue: 15~63mW/cm² Red: 31~75mW/cm² |
| **Additional Features** | | | | |
| Weight | 325g | 150g | AM-810B, AM-810W: 118g AM-812B, AM-812W: 130g | Unknown |
| Dimensions (mm) | 182*97.5*140 | 82*38*102 | AM-810B, AM-810W: 135*85*39mm | Unknown |
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| | | | AM-812B, AM-812W: 110*92*68mm | |
| --- | --- | --- | --- | --- |
| Main Materials | ABS /PC plastic, Silicone, Stainless steel | Body-safe silicone, ABS plastic, copper, glass, gold, zinc alloy | ABS, PC | Unknown |
| User interface | Power button ON/OFF Remote Control: LCD Screen Intensity +/- button Mode Switch button | Power button on/Off Deep cleansing mode button Regular cleansing mode button | Unknown | Unknown |
| Environment for operating | Temperature: +10°C~+35°C Relative humidity: 3%~75% RH Pressure: 70 Kpa~106 KPa | Temperature: 5 ~ 40°C Relative humidity:40% ~ 80% | Unknown | Unknown |
| Environment for storage | Temperature: -40°C~+70°C Relative humidity: 10%~95% RH Pressure: 50 Kpa~106 KPa | Temperature: -10 ~ 50° C Relative humidity: 30%~ 80% | Unknown | Unknown |
| Safety Information | | | | |
| Electrical Safety | IEC 60601-1 IEC 60601-1-2 | IEC 60601-1 IEC 60601-1-2 | IEC 60601-1 IEC 60601-1-2 | IEC60601-1-2 IEC60601-1 |
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| | IEC 60601-1-11 IEC 60601-2-10 IEC 60601-2-57 IEC 62471 | IEC 60601-2-10 IEC 62471 | IEC 60601-2-10 IEC 62471 | IEC60601-1-11 IEC60601-2-57 IEC 62471 |
| --- | --- | --- | --- | --- |
| Biocompatibility | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | Comply with ISO10993-1, ISO10993-5 and ISO10993-10 |
The technological characteristics, features, specifications, materials, and intended use of Facial Beauty Device (Facial Mask LED & EMS Beauty Device A-907) 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.
# **Substantially Equivalent (SE) Conclusion:**
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices K241102, K243430 and K230351.
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# 7 Summary for non-clinical test
The non-clinical testing was provided to demonstrate the subject device met the acceptance criteria of the test methodology or standards listed below.
# 1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the Facial Beauty Device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recommended by FDA. The following testing was performed to, and passed, including:
- ISO 10993-5: 2009, Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23: 2021, Biological evaluation of medical devices - Part 23: Tests for irritation
# 2) Electrical Safety
- IEC 60601-1:2005+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11:2020 Medical Electrical Equipment –Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-10:2012+A1:2016+A2:2023 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-2-57: 2023 for use in conjunction with IEC 60601-1:2005, 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
- IEC 62471:2006 Photobiological safety of lamps and lamp systems
# 3) Software Verification and Validation
Software documentation consistent with Basic Documentation Level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
# 8 Summary for clinical test
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Not applicable
## 9 Conclusion
The subject device Facial Beauty Device has all features of the predicate devices for intended use. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.
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