MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)

K252264 · Shenzhen Zhenxing Ruitong Technology Co., Ltd. · OHS · Oct 17, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K252264
• Device Name: MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)
• Applicant: Shenzhen Zhenxing Ruitong Technology Co., Ltd.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Oct 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light based device. - Red light: Treatment of full-face wrinkles. - Blue light (only suitable model JML1, JML3, JML5, JML6, JML9 Face mask): Treatment of mild to moderate inflammatory acne.

Device Story

MEGELIN LED Light Therapy Mask is an OTC wearable device for facial/neck skin treatment. Device uses LED arrays emitting red (660nm) or blue (460nm) light to treat wrinkles or acne, respectively. Operated by user via manual selection of treatment modes (10-20 min durations). Device is powered by rechargeable Li-ion battery. Output intensity varies by model (10-55 mW/cm²). Healthcare providers do not operate the device; users follow provided manual. Benefits include non-invasive skin therapy for specified conditions. Device construction includes silica gel, ABS, and polyurethane fiber.

Clinical Evidence

Bench testing only. No clinical data presented. Compliance verified via IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-83, 62471, 62133-2, and ISO 10993-5, 10993-10, 10993-23.

Technological Characteristics

Materials: Silica gel, ABS, Polyurethane fiber. Energy: LED light (Red 660±20nm, Blue 460±20nm). Power: Rechargeable Li-ion battery. Connectivity: Standalone. Software: Microprocessor-controlled. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471, IEC 62133-2, ISO 10993-5/10/23.

Indications for Use

Indicated for individuals aged 18+ for the treatment of full-face wrinkles (red light) and mild to moderate inflammatory acne (blue light, specific models only).

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

• LED Facial Mask, Model(s): MZ-01, NEWKEY-01, SP-FM-01 (K230351)
• LED Therapy Mask (MN1, M226) (K242385)

Reference Devices

• LED light therapy mask (FM-01, FM-02, FM-03) (K223544)
• BeneLife Premiun Facial Treatment Pack, Model:QZ0701A (K171647)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

October 17, 2025

Shenzhen Zhenxing Ruitong Technology Co., Ltd.
Li Guoyang
Certification Engineer
Room 25C, Microsoft Science and Technology Building
Nanshan District
Shenzhen, Guangdong 518000
China

Re: K252264

Trade/Device Name: MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)

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: July 10, 2025

Received: July 21, 2025

Dear Li Guoyang:

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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K252264 - Li Guoyang
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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-reporting-combination-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-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

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K252264 - Li Guoyang
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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TANISHA
L. HITHE-S
Digitally signed by
TANISHA L. HITHE-S
Date: 2025.10.17
17:56:01 -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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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. |
| --- | --- |
| 510(k) Number (if known) K252264 | |
| Device Name MEGELIN LED Light Therapy Mask Model(s): JML1, JML1+JML2, JML3, JM3+JML4, JML5, JML5+JM7, JML6, JML6+JML8, JML9, JML9+JML10 | |
| Indications for Use (Describe) The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light based device. • Red light: Treatment of full-face wrinkles. • Blue light (only suitable model JML1, JML3, JML5, JML6, JML9 Face mask): Treatment of mild to moderate inflammatory acne. | |
| 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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "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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Shenzhen Zhenxing Ruitong Technology Co., Ltd. 510(k)s -K252264 Summary

# 510(k) Summary of K252264

This “510(k) Summary” of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.

## Product Overview

### 1) SUBMITTER AND OWNER/OPERATOR:

Shenzhen Zhenxing Ruitong Technology Co., Ltd.

Room 25C, Microsoft Science and Technology Building, Nanshan District, Shenzhen

City, Guangdong CN 518000

Contact Person: Guoyang Li

Email: [e-mail]

Date prepared: Oct, 15, 2025

### 2) Product Information

Trade Name: Product name: MEGELIN LED Light Therapy Mask

Model(s): JML1, JML1+JML2, JML3, JM3+JML4, JML5, JML5+JM7, JML6, JML6

+JML8, JML9, JML9+JML10

Common Name: Light Based Over The Counter Wrinkle Reduction;

Over-the-counter powered light-based laser for acne

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulation Number: 21 CFR 878.4810

Product Code: OHS, OLP

Review Panel: General & Plastic Surgery

### 3) Predicate devices

Primary Predicate device 1

| Sponsor | Shenzhen SUNGPO HI-TECH Electronic Co.,Ltd |
| --- | --- |
| Device Name and Model | LED Facial Mask, Model(s): MZ-01, NEWKEY-01, SP-FM-01 |
| 510(k) Number | K230351 |
| Product Code | OHS, OLP |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | Class II |

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Shenzhen Zhenxing Ruitong Technology Co., Ltd. 510(k)s -K252264 Summary

## Predicate device2

| Sponsor | Shenzhen Borria Technology Co., Ltd |
| --- | --- |
| Device Name and Model | LED Therapy Mask (MN1, M226) |
| 510(k) Number | K242385 |
| Product Code | OHS, OLP,ILY |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | Class II |

## Reference device 1

| Sponsor | Guangdong Newdermo Biotech Co.,Ltd |
| --- | --- |
| Device Name and Model | LED light therapy mask (FM-01, FM-02, FM-03) |
| 510(k) Number | K223544 |
| Product Code | OHS, OLP,ILY |
| Regulation Number | 21 CFR 878.4810
21 CFR 890.5500 |
| Regulation Class | Class II |

## Reference device 2

| Sponsor | Infinitus (China) Company Ltd. |
| --- | --- |
| Device Name and Model | BeneLife Premiun Facial Treatment Pack ,
Model:QZ0701A |
| 510(k) Number | K171647 |
| Product Code | NFO, OHS |
| Regulation Number | 21 CFR 882.5890
21 CFR 878.4810 |
| Regulation Class | Class II |

## 4) Device Description

The MEGELIN LED Light Therapy Mask uses blue light (460nm) to treat acne. The MEGELIN LED Light Therapy Mask uses red light (660nm) to irradiate on the facial skin that help reduce wrinkles.

JML1, JML3, JML5, JML6, JML9 are face masks, with the only difference in energy density setting, while JML2, JML4, JML7, JML8, JML10 are neck masks with the only difference in energy density setting.

## 5) Proposed Conditions of Use

> Intended Use:

The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light

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Shenzhen Zhenxing Ruitong Technology Co., Ltd. 510(k)s -K252264 Summary

based device.

- Red light: Treatment of full-face wrinkles.
- Blue light (only suitable model JML1, JML3, JML5, JML6, JML9 Face mask): Treatment of mild to moderate inflammatory acne.

> Indications: Same as the Intended Use.
> Treatment Area: Face and Neck.

> Target Population:
> The MEGELIN LED Light Therapy Mask is for the crowd aged over 18 years. It can be operated by professional personnel or persons with certain knowledge (the person can study by means of reading the product user manual).

> The Service Life of the Product:
> Product lifetime: 5 years
> Li-battery: More than 1000 hours

> Cleaning Frequency:
> Clean whenever the exterior surface is dirty.
>
> Dampen a dust-free cloth or non-woven fabric with clean water and clean the areas with dust.

## 6) Comparison with Predicate Device:

The MEGELIN LED Light Therapy Mask has the same intended use as the predicate devices. The technological characteristics such as wavelength, intensity, are similar to the predicate devices and reference devices. Any minor differences between the subject device and the listed predicate devices and reference devices do not raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use.

Therefore, the MEGELIN LED Light Therapy Mask may be found substantially equivalent to its predicate devices

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Shenzhen Zhenxing Ruitong Technology Co., Ltd. 510(k)s -K252264 Summary

| Items | Subject device | Primary Predicate device 1 | predicate device 2 | Reference device 1 | Reference device 2 | Difference discussion |
| --- | --- | --- | --- | --- | --- | --- |
| K number | K252264 | K230351 | K242385 | K223544 | K171647 | / |
| Device trade name | MEGELIN LED Light Therapy Mask, Model: JML1, JML1+JML2, JML3, JM3+JML4, JML5, JML5+JM7, JML6, JML6+JML8, JML9, JML9+JML10 | LED Facial Mask/ MZ-01, NEWKEY01, SP-FM-01 | LED Therapy Mask (MN1, M226) | LED light therapy mask (FM-01, FM-02, FM-03) | BeneLife Premium Facial Treatment Pack ,Model:QZ0 701A Model: EP-300 | / |
| Product Code | OHS, OLP | OHS, OLP | OHS, OLP, ILY | OHS, OLP,ILY | NFO, OHS | Same |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 21 CFR 890.5500 | 21 CFR 882.5890, 21 CFR 878.4810 | Same |
| Device Class | Class II | Class II | Class II | Class II | Class II | Same |
| Intended use | The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light based device. Red light: Treatment of full-face wrinkles. Blue light (only suitable model JML1,JML3, JML5, JML6,JML9 Face mask): Treatment of mild to moderate inflammatory acne. | 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. | Red light: Treatment of full-face wrinkles. Blue light (only suitable model M226 and MN1 LED Facial Mask):Treatment of mild to Moderate inflammatory acne. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. | Red light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm. relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. | The micro current stimulation mode is intended for facial stimulation and is indicated for over-the counter cosmetic use. The red light treatment function is intended for the treatment of periorbital wrinkles. | Same |

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Shenzhen Zhenxing Ruitong Technology Co., Ltd. 510(k)s -K252264 Summary

| | | | tissue; and to temporarily increase local blood circulation. Mixed light: Treatment of full face wrinkles. | Mixed light: Treatment of mild to moderate inflammatory acne. | | |
| --- | --- | --- | --- | --- | --- | --- |
| Prescription/OTC | OTC | OTC | OTC | OTC | OTC | Same |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Yes | Yes | Same |
| Intended location of use | Mask and Neck | Mask | Face and Neck | Mask | Mask | Same |
| Treatment size | JML1, JML3, JML5, JML6, JML9: 330cm² JML1+JML2, JML3+JML4, JML5+JML7, JML6+JML8, JML9+JML10: 660cm² | Unknown | MN1: LED Facial Mask: 300*208.5*5.5mm LED Neck Mask: 338.5*249.7*5.5mm M226: LED Facial Mask: 300*208.5*5.5mm | FM-01: 207X277X43mm, FM-02: 198X383X33.5mm, FM-03: 237.5X108X8.1mm | | Different Note 1 |
| Energy type | LED | LED | LED | LED | LED | Same |
| Wavelength | Red 660±20nm Blue: 460±20nm | Blue: 465nm±5nm Red: 625nm±5nm Amber: 605nm±5nm | Red: 630nm±5nm Blue: 470 nm±5nm Near-Infrared: 850nm±5nm Mixed light: 630nm and 850nm | Red: 620nm Blue: 460nm Infrared: 850nm Mixed: 620nm and 850nm and 460nm | 660±5nm | Similar Note 2 |

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Shenzhen Zhenxing Ruitong Technology Co., Ltd. 510(k)s -K252264 Summary

| Intensity (mW/cm²) | JML1, JML1+JML2: Red: 10mW/cm²
Blue: 15mW/cm²
JML3, JML3+JML4: Red: 15mW/cm²
Blue: 25mW/cm²
JML5, JML5+JML7: Red: 20mW/cm²
Blue: 35mW/cm²
JML6, JML6+JML8: Red: 25mW/cm²
Blue: 45mW/cm²
JML9, JML9+JML10: Red: 35mW/cm²
Blue: 55mW/cm² | Blue: 15~63mW/cm²
Red: 31~75mW/cm²
Amber: 15~42mW/cm² | Red: 0.89~2.55mW/cm²
Blue: 1.44~4.09mW/cm²
Near-Infrared: 1.83~3.05mW/cm²
Mixed light: 0.95~2.64mW/cm² | Red light: 2.0~3.0mW/cm²
Blue light: 2.0~4.0mW/cm²
Infrared light: 2.0~4.0mW/cm²
Mixed light: 9.0~12.0mW/cm² | Red :80mW/cm² | Similar Note 3 |
| --- | --- | --- | --- | --- | --- | --- |
| Power supply | Rechargeable Li-ion battery | External adapter Input: AC100-240V 50-60Hz
Output: DC 12V 0.5A | Input: DC 5V, 1A
Built-in rechargeable lithium battery: DC 3.7V 2500mAh | Unknown | 3.7V 2600 mAh rechargeable lithium battery | Different Note 4 |
| Treatment time | 10/ 15/ 20 minutes(blue light limited to 10 minutes). | 10 minutes/day, 3 times per week | 10 minutes each time | Manual Mode: 15minutes each time, Automatic Mode: 10minutes each time. | Red light mode: 3 minutes | Similar |
| Main materials | Silica gel, ABS, Polyurethane Fiber | ABS and PC plastic | Unknown | Unknown | Unknown | Different, but solved by biocompatibility test |

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Shenzhen Zhenxing Ruitong Technology Co., Ltd. 510(k)s -K252264 Summary

| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 10993-23 | Comply with ISO10993-1, ISO 10993-5 and ISO 10993-10 | All body-contacting materials are complied with ISO 10993-5, ISO 10993-10 and ISO 10993-23 | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 requirements. | Same |
| --- | --- | --- | --- | --- | --- | --- |
| Electrical safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83
IEC 62471
IEC 62133-2 | IEC60601-1-2
IEC60601-1
IEC60601-1-11
IEC60601-2-57
IEC62471 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83
IEC 62471
IEC 62133-2 | IEC 60601-1;
IEC 60601-1-2
IEC60601-1-11
IEC60601-2-57 | Comply with IEC 60601-1
IEC62471
Comply with IEC 60601-1-2 | Same |

## Comparison in details:

**Note 1:**
The treatment size is different from the predicate devices and reference devices, but the subject device is a mask design device that is the same as the primary predicate device and predicate device 1, so this difference does not raise any new issues of safety or effectiveness.

**Note 2:**
Though the wavelength of the subject device is a little different from the primary predicate device, the wavelength of the blue light (460±20nm) of the subject device is basically the same as that of the primary predicate device, while the red light (660±20nm) is the same as the reference device 2, and the subject device complies with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.

**Note 3:**
Though the intensity of the subject device is a slightly different from the predicate devices, the intensity range of blue light of the subject device is within the range of that of the primary predicate device, while the intensity range of the red light is within the minimum and maximum range of the predicate devices and reference device 1, and the subject device complies with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.

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Shenzhen Zhenxing Ruitong Technology Co., Ltd. 510(k)s -K252264 Summary

Note 4:
The power supply for the subject device is different from that of the predicate devices, however the lithium battery of the subject device has passed IEC 62133-2 test, so this difference should not raise any safety/effectiveness questions.

7) Non-clinical studies and tests performed:

Non-clinical testing have been conducted to verify that the MEGELIN LED Light Therapy Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:

- IEC 60601-1:2020, 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 compatibility
- 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 60601-2-83:2022, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- IEC 62471:2006, Photobiological safety of lamps and lamp systems
- IEC 62133-2:2021, 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

The device has been tested for biocompatibility; it complies with the following standards.

- ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity

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Shenzhen Zhenxing Ruitong Technology Co., Ltd. 510(k)s -K252264 Summary

- 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

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) Conclusions

MEGELIN LED Light Therapy Mask is substantially equivalent to the predicate device in indications for use and technological characteristics. Any differences that may exist between the subject and predicate devices do not raise questions of safety and effectiveness. MEGELIN LED Light Therapy Mask is as safe, as effective, and performs as well as the predicate devices.