(150 days)
Multi-functional Facial Beauty Device (model: SKB-1909):
- Blue light is intended for the treatment of facial mild to moderate inflammatory acne.
- Red light is intended for the treatment of facial wrinkles.
Multi-functional Facial Beauty Device (model: SKB-1703):
- Blue light is intended for the treatment of facial mild to moderate inflammatory acne.
Multi-functional Facial Beauty Device (models SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB-2209):
- Red light is intended for the treatment of facial wrinkles.
The Multi-functional Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.
The device is only home environment use, which has some massage heads, and LED light mode (Red and /or Blue lights are output independently) to provides following functions.
a. Micro-current stimulation function.
b. Red LED irradiation function.
c. Blue LED irradiation.
d. Hot compress and vibration function.(The vibration is classified as class I and not need for 510K, and the hot compress (39℃±0.5℃) is not for medical purpose).
e. Hot compress function.(The hot compress (35.5℃～38.5±0.5℃) is not for medical purpose).
f. Vibration function.(The vibration is classified as class I and not need for 510K).
Each mode of the Multi-functional Facial Beauty Device is independent from all other modes of the device.
N/A
FDA 510(k) Clearance Letter - Multi-functional Facial Beauty Device
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.0 8 . 0 2
Silver Spring, MD 20993
www.fda.gov
December 5, 2025
Shenzhen Siken 3D Technology Development Co., Ltd.
℅ Bing Huang
Registration Specialist
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center, No. 3101-90
Qianhai Road
Shenzhen, Guangdong 518052
China
Re: K252142
Trade/Device Name: Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
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
Dated: November 12, 2025
Received: November 12, 2025
Dear Bing Huang:
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
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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 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 (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.
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-advicecomprehensive-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-reportingmdr-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/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Page 3
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-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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.12.05 14:34:31 -05'00'
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K252142
Device Name: Multi-functional Facial Beauty Device (SKB-1703, SKB-1803, SKB-1809, SKB-1909, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209)
Indications for Use (Describe)
Multi-functional Facial Beauty Device (model: SKB-1909):
- Blue light is intended for the treatment of facial mild to moderate inflammatory acne.
- Red light is intended for the treatment of facial wrinkles.
Multi-functional Facial Beauty Device (model: SKB-1703):
- Blue light is intended for the treatment of facial mild to moderate inflammatory acne.
Multi-functional Facial Beauty Device (models SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB-2209):
- Red light is intended for the treatment of facial wrinkles.
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.
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:
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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."
Page 5
510(k) Summary #K252142
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2025-11-24
I. Submitter
Shenzhen Siken 3D Technology Development Co., Ltd.
Room 1104, Building 2, Xinweirun High-tech Park, No. 162, Shajiang Road, Xitou Community,
Shajiang Road, Songgang Street, Bao'an District, Shenzhen, Guangdong, China.
Post code: 518105
Tel.: +86-0755-27697523
Jing Quan Liu
Title: Management representative
Tel.: +86-0755-27697523
Email: 1550420556@qq.com
II. Device
Name of Device: Multi-functional Facial Beauty Device (SKB-1703, SKB-1803, SKB-1809, SKB-1909, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209)
Common or Usual Name: Light Based Over The Counter Wrinkle Reduction Over-The-Counter Powered Light Based For Acne
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: OHS, OLP
Regulation Number: 21 CFR 878.4810
III. Predicate Device & Reference Device
Predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Cleared Date |
|---|---|---|---|
| Galactic Beauty, LLC | MMSphere™ | K190443 | June 24, 2019 |
| Shenzhen Aozemei Technology Co., LTD | Micro-current Facial Beauty Device (Model(s): AM-810W, AM-810B, AM-812W, AM-812B) | K241718 | October 28, 2024 |
Reference device:
| Manufacturer | Reference Device | 510(k) Number | Cleared Date |
|---|---|---|---|
| Li-Tek Electronics Technology Co., Ltd. | Micro-current facial cold and hot service (model: TPML-100) | K213039 | May 25, 2022 |
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IV. Device Description
The Multi-functional Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.
The device is only home environment use, which has some massage heads, and LED light mode (Red and /or Blue lights are output independently) to provides following functions.
a. Micro-current stimulation function.
b. Red LED irradiation function.
c. Blue LED irradiation.
d. Hot compress and vibration function.(The vibration is classified as class I and not need for 510K, and the hot compress (39℃±0.5℃) is not for medical purpose).
e. Hot compress function.(The hot compress (35.5℃～38.5±0.5℃) is not for medical purpose).
f. Vibration function.(The vibration is classified as class I and not need for 510K).
Each mode of the Multi-functional Facial Beauty Device is independent from all other modes of the device.
V. Indications for Use
Multi-functional Facial Beauty Device (model: SKB-1909):
- Blue light is intended for the treatment of facial mild to moderate inflammatory acne.
- Red light is intended for the treatment of facial wrinkles.
Multi-functional Facial Beauty Device (model: SKB-1703):
- Blue light is intended for the treatment of facial mild to moderate inflammatory acne.
Multi-functional Facial Beauty Device (models SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB-2209):
- Red light is intended for the treatment of facial wrinkles.
VI. Comparison of Technological Characteristics With the Predicate Device
Multi-functional Facial Beauty Device is compared with the following Predicate Devices and Reference device in terms of intended use, design, specifications, and performance:
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| Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Reference device | Remark |
|---|---|---|---|---|---|
| 510(k) Number | K252142 | K190443 | K241718 | K213039 | / |
| Trade name | Multi-functional Facial Beauty Device (Model(s):SKB-1703,SKB-1803,SKB-1809, SKB-1909,SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | MMSphere™ | Micro-current Facial Beauty Device (Model(s): AM-810W, AM-810B, AM-812W, AM-812B) | Micro-current vibration facial cold and hot service (model: TPML-100) | / |
| Manufacturer | Shenzhen Siken 3D Technology Development Co., Ltd | Galactic Beauty, LLC | Shenzhen Aozemei Technology Co., LTD | Li-Tek Electronics Technology Co., Ltd. | / |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHS, OLP | OHS, OLP | OHS, OLP | OHS, OLP | Same |
| Device classification | II | II | II | II | Same |
| Prescription or OTC | OTC | OTC | OTC | OTC | Same |
| Indication for use/ Intended use | Multi-functional Facial Beauty Device (model: SKB-1909): - Blue light is intended for the treatment of | MMSphere™ Light Therapy Device emits energy in the red, blue and amber regions of the spectrum, specifically indicated to treat wrinkles and/or mild to moderate acne. The | Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. | Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation | Same |
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| Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Reference device | Remark |
|---|---|---|---|---|---|
| facial mild to moderate inflammatory acne. - Red light is intended for the treatment of facial wrinkles. Multi-functional Facial Beauty Device (model: SKB-1703): - Blue light is intended for the treatment of facial mild to moderate inflammatory acne. Multi-functional Facial Beauty Device (models SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB-2209): - Red light is intended for the treatment of facial wrinkles. | MMSphere™ is designed to be used for 20 minute treatments three to seven times per week. | for over the counter aesthetic use. | |||
| Handheld or stationary | Hand-held Type | Both | Hand-held Type | Hand-held Type | Same |
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| Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Reference device | Remark |
|---|---|---|---|---|---|
| Irradiance source | LEDs | LEDs | LEDs | LEDs | |
| Anatomical sites | Entire Face | Entire Face | Entire Face | Entire Face | |
| Wavelength | SKB-1909: Red light: 630nm±10nm Blue light:460nm±10nm SKB-1703: Blue light:460nm±10nm SKB-1803, SKB-1809, SBK-2109,SKB-2129, SKB-2208PRO and SKB-2209: Red light: 630nm±10nm | 605nm 625nm 465nm | 415±10nm blue light 605±10nm amber light 630±10nm red light | Blue light: 415±10 nm Red light: 630±10 nm | Same |
| Power Intensity | SKB-1909: Red light: 2.3mW/cm² Blue light:1.33mW/cm² SKB-1703: Blue light:1.33mW/cm² SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB-2209: Red light: 2.3mW/cm² | Red 2.45mW/cm² Blue 1.33mW/cm² | Red light: 2.5mW/cm² Amber light: 15mW/cm² Blue light: 1.4mW/cm² | Blue light: 25 mw /cm²±10% Red light: 45mw /cm²±10% | Same |
| Hot compress temperature | SKB-1809/SKB-2209: THERMO(Hot compress): | / | Hot compress and vibration function: 40±1℃ | Warming function: 44±2℃ | Similar |
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| Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Reference device | Remark |
|---|---|---|---|---|---|
| 35.5～38.5℃±0.5℃ SKB-1909: THERMO(Hot compress): 35.5～38.5℃±0.5℃ THERMO+VIB(Hot compress and vibration function): 39±1℃ | |||||
| Motor vibration | SKB-1703,SKB-1809,SKB-1909,SKB-2209: Motor vibration | / | Motor vibration | Micro motor | Same |
| Electrical safety | IEC 60601-1 IEC 60601-1-11 IEC 62471 IEC 60601-2-57 IEC 60601-1-2 IEC 62133-2 | IEC 60601-1 IEC 60601-1-11 IEC 60601-1-6 IEC 62471 IEC 60601-2-57 IEC 60601-1-2 IEC 62133-2 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-10 IEC 60601-2-57 | Same |
| Biocompatibility feature | All patient contacting materials are complied with ISO 10993-5, ISO 10993-10 and ISO 10993-23 | All patient contacting materials are complied with ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 | Same |
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VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Safety
The materials of the patient-directly contacting components of the subject device is performed the biocompatibility evaluation 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 and EMC Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility
- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION, Medical Electrical Equipment –Part 1: 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 60601-2-57:2011 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
- IEC 62133-2:2022 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
3) Eye Safety
- IEC 62471:2006 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Software documentation consistent with Basic Documentation 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.
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Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate devices.
VIII. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design and performance, it can be concluded that the Multi-functional Facial Beauty Device is substantially equivalent to the legally marketed predicate devices.
§ 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.