LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
Device Facts
| Record ID | K254025 |
|---|---|
| Device Name | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) |
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd. |
| Product Code | OHS · General, Plastic Surgery |
| Decision Date | Jun 16, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
M1 is an over-the-counter device that is intended for emit energy in the red and infrared spectrum for use for the treatment of full face and decolletage wrinkles. M2,M3,M5 is an over-the-counter device that is intended for emit energy in the red,infrared, yellow spectrum for use for the treatment of full face wrinkles. M4 is intended for over-the-counter use to treat mild to moderate inflammatory acne on the face.
Device Story
Wearable, battery-powered LED mask; emits red (630nm), infrared (830nm), blue (465nm), and yellow (590nm) light; used for wrinkle reduction and acne treatment. Device features single-button interface for power and mode selection; 10-minute automatic treatment timer. Used in home environment by patient; includes goggles and adjustable Velcro strap. Output is light energy delivered to skin; intended to improve appearance of wrinkles and reduce inflammatory acne. Powered by rechargeable lithium-ion battery.
Clinical Evidence
No clinical data. Bench testing only, including electrical safety (IEC 60601-1, -1-2, -1-11, -2-83), photobiological safety (IEC 62471), battery safety (IEC 62133-2), biocompatibility (ISO 10993-1), software verification/validation, and usability testing.
Technological Characteristics
Wearable LED mask; lithium-ion battery (7.4V, 2600mAh). Wavelengths: 465nm, 590nm, 630nm, 830nm. Irradiance: 6-14 mW/cm² depending on wavelength. Biocompatibility per ISO 10993-1, -5, -10, -23. Electrical safety per IEC 60601-1, -1-2, -1-11, -2-83. Photobiological safety per IEC 62471. Battery safety per IEC 62133-2.
Indications for Use
Indicated for OTC treatment of mild to moderate inflammatory acne on the face, and wrinkles on the full face and decolletage.
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
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 16, 2026
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Alain Dijkstra
Official Correspondent
Bldg.#3 And Bldg.#5, 40th Of Fuxin St.
Huaide Community Fuyong Town, Baoan District
Shenzhen, Guangdong 518103
China
Re: K254025
Trade/Device Name: LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
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: December 16, 2025
Received: December 16, 2025
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K254025 - Alain Dijkstra
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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 (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-
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K254025 - Alain Dijkstra
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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: 2026.06.16
19:32:49 -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
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K254025
Device Name
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
Indications for Use (Describe)
M1 is an over-the-counter device that is intended for emit energy in the red and infrared spectrum for use for the treatment of full face and decolletage wrinkles.
M2,M3,M5 is an over-the-counter device that is intended for emit energy in the red,infrared, yellow spectrum for use for the treatment of full face wrinkles.
M4 is intended for over-the-counter use to treat mild to moderate inflammatory acne on the face.
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)
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# K254025 - 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
## 1. 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 (CEO)
Tel: +86-135-10378748
Fax: +86-755-25024651
E-mail: registrar01@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: registrar01@kaiyanmedical.com
## 2. Subject Device Information:
Trade Name: LED Neck Beauty Mask, Model: ZLD-180H;ZLD-130;ZLD-90E;ZLD-66A
Classification Name: Light Based Over the Counter Wrinkle Reduction;Over-The-Counter Powered Light
Based Laser For Acne
Review Panel: General & Plastic Surgery
Product Code: OHS,OLP
Regulation Number:21 CFR 878.4810
Regulation Class: II
## 3. Predicate Device Information
### Predicate Device 1 (K240089)
Sponsor: Shenzhen Kaiyan Medical Equipment Co., Ltd
Trade Name: Face Patches
Classification Name: Light Based Over the Counter Wrinkle Reduction;Over-The-Counter Powered Light
Based Laser For Acne;Laser surgical instrument for use in general and plastic surgery and in dermatology.
Review Panel: General & Plastic Surgery
Product Code: OHS,OLP,GEX
Regulation Number: 21 CFR 878.4810
Regulation Class: II
### Predicate Device 2 (K243492)
Sponsor: Shenzhen Ulike Smart Electronics Co.,Ltd.
Trade Name: Ulike Reglow Light Therapy Device
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Classification Name: Light Based Over the Counter Wrinkle Reduction;Over-The-Counter Powered Light Based Laser For Acne
Review Panel: General & Plastic Surgery
Product Code: OHS,OLP
Regulation Number: 21 CFR 878.4810
Regulation Class: II
# **Predicate Device 3 (K242382)**
Sponsor: ISMART Developments Ltd
Trade Name: décoLITE
Classification Name: Light Based Over the Counter Wrinkle Reduction;
Review Panel: General & Plastic Surgery
Product Code: OHS
Regulation Number: 21 CFR 878.4810
Regulation Class: II
# **4. Device Description**
The LED Neck Beauty Mask (Model: ZLD-66A/ZLD-90E/ZLD-130/ZLD-180H) is a wearable, battery-powered device used for treatment of mild to moderate acne on the face, and wrinkles around the face and decolletage by emitting LED red(630nm),infrared(830nm),blue(465nm) and yellow(590nm)light. The device is powered by a Lithium-Ion rechargeable battery, and it has charging cable,adjustable Velcro,goggles, storage bag and instruction manual.
The device has only one button to power on/off and switch the modes,press long to power on/off,press short to switch the treatment modes.
The recommend treatment time is 10min per area, when the user choose the mode and treatment automatically completed after 10minutes.If you need to continue treatment, simply turn on the device again.
# **5. Intended Use / Indications for Use**
M1 is an over-the-counter device that is intended for emit energy in the red and infrared spectrum for use for the treatment of full face and decolletage wrinkles.
M2,M3,M5 is an over-the-counter device that is intended for emit energy in the red,infrared,yellow spectrum for use for the treatment of full face wrinkles.
M4 is intended for over-the-counter use to treat mild to moderate inflammatory acne on the face.
# **6. Comparison to predicate devices**
Compare with the predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions 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 1 (K240089) | Predicate device 2 (K243492) | Predicate device 3 (K242382) | Remark |
| --- | --- | --- | --- | --- | --- |
| | | | | | |
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| Elements of Comparison | Subject device | Predicate device 1 (K240089) | Predicate device 2 (K243492) | Predicate device 3 (K242382) | Remark |
| --- | --- | --- | --- | --- | --- |
| Manufacturer | Shenzhen Kaiyan Medical Equipment Co., Ltd | Shenzhen Kaiyan Medical Equipment Co., Ltd | Shenzhen Ulike Smart Electronics Co.,Ltd. | ISMART Developments Ltd | -- |
| 510 (K) Number | K254025 | **K240089** | **K243492** | **K242382** | -- |
| Device Name | LED Neck Beauty Mask | Face Patches | Ulike Reglow Light Therapy Device | décoLITE | -- |
| Model | ZLD-180H; ZLD-130; ZLD-90E; ZLD-66A | MT-12MA, MT-12MC | UM10 | / | -- |
| OTC/Rx | OTC | OTC | OTC | OTC | Same |
| Regulation Class | Class II | Class II | Class II | Class II | Same |
| Product Code | OHS+OLP | OHS,OLP,GEX | OHS+OLP | OHS | Same |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Indications for Use / Intended use | M1 is an over-the-counter device that is intended for emit energy in the red and infrared spectrum for use for the treatment of full face and decolletage wrinkles. M2,M3,M5 is an over-the-counter device that is intended for emit energy in the red,infrared,yellow spectrum for use for the treatment of full face wrinkles. M4 is intended for over-the-counter use to treat mild to moderate inflammatory acne on the face. | Face Patches (Model: MT-12MA) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne. Face Patches (Model: MT-12MC) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne and full-face wrinkles (including periorbital wrinkles). | Ulike Reglow Light Therapy Device is an over the counter device that is intended for use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne. | The décoLITE LED device is an over-the-counter device that is intended for the use in the treatment of wrinkles in the decolletage area. | Similar (Note 1) |
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| Elements of Comparison | Subject device | Predicate device 1 (K240089) | Predicate device 2 (K243492) | Predicate device 3 (K242382) | Remark |
| --- | --- | --- | --- | --- | --- |
| Intended Location Use | Face, decolletage | Face | Face | Decolletage (upper chest) | Similar (Note 2) |
| Power Source | Lithium battery: 7.4V, 2600mAh, 19.24W | Controller: 3.6V, 65mAh lithium battery, 0.234Wh | Controller: 3.7V, 2600mAh lithium battery, 9.62Wh | Not available | Similar (Note 3) |
| Irradiance source | LED | LED | LED | LED | Same |
| LED wavelength | Winkle For face and decolletage: M1:630+830 For face: M2:830+590 M3:630+590 M5:630+830+590 Acne M4:630+465 | MT-12MA: 630±10nm 415+10nm MT-12MC: 415nm±10nm, 630nm ±10nm, 830nm ±10nm, 590nm ±10nm | 465nm, 590nm, 630nm, 830nm | Red: 630nm ± 10nm NIR: 830nm ± 10nm | Similar (Note 4) |
| Irradiances(m w/cm²) | 465nm:8-12 mW/cm², 630nm:8-12 mW/cm², 830nm:10-14mW/cm², 590nm:6-10 mW/cm² | For MT-12MA: 630nm:5 415nm:25 630+415nm:30 For MT-12MC 630nm(type 1):5 415nm: 25 Mode 1-total: 30 830nm:15 630nm(type 2):20 Mode 2-total: 35 Mode 3-590nm:35 | 1-40 | 30 total | Similar (Note 4) |
| Treatment Time | 10mins per treatment | For MT-12MA (630+415nm):3 minutes per treatment For MT-12MC (mode 1 - 630+415nm):3minutes per treatment | Not available | 600 seconds (10 minutes) 5× weekly, 6 weeks | Similar (Note 4) |
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| Elements of Comparison | Subject device | Predicate device 1 (K240089) | Predicate device 2 (K243492) | Predicate device 3 (K242382) | Remark |
| --- | --- | --- | --- | --- | --- |
| | | For MT-12MC (mode 2 - 630+830nm):9minutes per treatment For MT-12MC(mode 3 - 590nm):21 minutes per treatment | | | |
| Electrical Safety | Compliant with IEC 60601- 1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83 IEC 62471 | Compliant with IEC 60601- 1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57 IEC 62471 | Compliant with IEC 60601- 1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83 IEC 62471 | IEC 60601- 1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57 IEC 60601-2-83 IEC 62471 | Same |
| Biocompatibility | ISO 10993-1 ISO10993-5 ISO10993-10 ISO 10993-23 | ISO 10993-1 ISO10993-5 ISO10993-10 ISO 10993-23 | ISO10993-5 ISO10993-10 ISO 10993-23 | unknown | Same |
#### Comparison in Detail(s):
##### **Note 1:**
The Intended use of subject device is to treat mild to moderate acne on the face, and wrinkles around the face and decolletage, which is slightly different from predicate devices 1,2 and 3 .
##### **Note 2:**
The intended location use of the subject device is for face and decolletage, which is same as the predicate device 1,2(for face),3(for decolletage).
##### **Note 3:**
The power supply for the subject device is a little different from that of the predicate device, however the lithium battery of the subject device has been tested under standard IEC 62133-2, so this difference should not raise any safety/effectiveness issues.
##### **Note 4:**
The subject device is a little different from the predicate device 2 in terms of 'Treatment Time' and 'Irradiances', however they have the same LED wavelengths ; And the 'Treatment time', 'wavelength' and 'Irradiances' of the subject device are very close to those of predicate device 1, 3; so it can be
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concluded that the subject device can achieve the same treatment effect (wrinkle treatment and mild to moderate acne )as the predicate devices. In addition, all of them have passed the tests of IEC 60601-1,IEC 60601-1-11 and IEC 60601-2-83, these differences will not raise any new safety or effectiveness issues.
## 7. Test Summary
### 7.1 Non-Clinical Tests Performed
#### 1) Electrical safety, and electromagnetic compatibility Test
Non-clinical tests were performed on the subject device to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Edition 2.1 2020-07 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 60601-2-83:2019+AMD1:2022 Edition 1.1 Medical Electrical Equipment - Part 2-83- Particular requirements for the basic safety and essential performance of home light therapy equipment.
- IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems.
- IEC 62133-2:2017+AMD1:2021 Edition1.1 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.
#### 2) Biological Compatibility Statement
The component of the LED Neck Beauty Mask (Model: ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) has been conformed to ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
#### 3) Software verification and validation
Software verification and validation testing was conducted and basic documentation provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
#### 4) Usability validation
Usability testing was conducted on the LED Neck Beauty Mask(Model: ZLD-180H;ZLD-130;ZLD-90E;ZLD-66A).
### 7.2 Summary of Clinical Performance
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.
## 8. Date of the summary prepared: June 4, 2026
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# **9. Final Conclusion**
The subject device is equally safe, effective, and performs as well or better than the legally marketed predicated devices K240089,K243492,K242382.
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