Введение
On June 9, 2025, США. Управление по контролю за продуктами и лекарствами (FDA) issued a 510(k) substantial equivalence determination for our Светодиодная светотерапевтическая маска under the official clearance number K250830.
This clearance covers 13 device models and authorizes their distribution in the United States as a Class II Over-The-Counter (OTC) медицинское устройство for two specific indications: full-face wrinkle treatment и mild-to-moderate inflammatory acne treatment.
This article provides the complete public record of K250830, sourced directly from the FDA Clearance Letter, FDA 510(k) База данных предмаркетинговых уведомлений, and the FDA Product Classification database. Every figure, name, and date below can be independently verified.🔗 Verify on FDA Link.
1. Official FDA 510(k) Clearance Profile
The following table reproduces the public record verbatim from the FDA database and the official Clearance Letter:
| Field | Official Record |
|---|---|
| 510(k) Number | K250830 |
| Device Classification Name | Light Based Over The Counter Wrinkle Reduction |
| Trade / Device Name | Светодиодная светотерапевтическая маска |
| Applicant | Компания Shenzhen Sungrow LED Technology Co., ООО. |
| Applicant Address | 3Фон 2# Заводской корпус (Фаза I), Sci Carcass & Tech Industrial Park, Промышленный парк высоких технологий Гуанмина, Шэньчжэнь, CN 518000 |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Name | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology |
| Regulatory Class | Класс II |
| Product Code (Primary) | OHS |
| Product Code (Subsequent) | OLP |
| Type of Use | Over-The-Counter (OTC) — 21 CFR 801 Subpart C |
| Submission Type | Traditional 510(k) |
| Date Received by FDA | March 19, 2025 |
| Decision Date | June 9, 2025 |
| FDA Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | General & Plastic Surgery |
| 510(k) Review Panel | General & Plastic Surgery |
| Premarket Review Office | Office of Surgical and Infection Control Devices (OHT4) — Division of General Surgery Devices (DHT4A) |
| Combination Product | Нет |
| Implanted Device | Нет |
| Life-Sustaining / Life-Support | Нет |
| Reviewed by Third Party | Нет |
| Predetermined Change Control Plan Authorized | Нет |
| Signed by | Tanisha L. Hithe, Assistant Director, FDA CDRH |
2. А 13 Device Models Covered by K250830
The FDA Clearance Letter explicitly lists the following 13 модели as covered under K250830:
G15, G15p, Г15К, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK
Все 13 models share the same intended use, regulatory classification, and indications for use as cleared by the FDA. Each model is authorized for sale in the United States as an OTC Class II medical device.
💡 Примечание: Different model designations correspond to different form factors (full face mask, neck/chest mask, or face-and-body combinations). Detailed product specifications for each model are available on the respective product pages.
3. FDA-Cleared Indications for Use
The following indications are reproduced word-for-word from FDA Form 3881, the official Indications for Use form filed with K250830:
| Light Mode | FDA-Cleared Indication |
|---|---|
| Красный свет | Treatment of full-face wrinkles |
| Желтый свет | Treatment of full-face wrinkles |
| Красный + Инфракрасный свет | Treatment of full-face wrinkles |
| Синий свет | Treatment of mild to moderate inflammatory acne |
| Mixed light (Красный + Синий + Инфракрасный) | Treatment of mild to moderate inflammatory acne |
⚠️ Compliance note: Marketing communications for these devices in the United States must not exceed these specific indications. Claims regarding hyperpigmentation, scarring, рост волос, облегчение боли, or other conditions are нет covered by K250830 and should not be made without separate regulatory authorization.
4. What “Light Based Over The Counter Wrinkle Reduction” Means (FDA Definition)
The FDA Product Classification Database defines our product code OHS as follows (verbatim):
Определение: “Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.”
Physical State: “The device can be hand held or mounted on a support system like a stand or mechanical arm. The device will emit light that can be monochromatic or narrow band or broad band. The light energy may be very low to moderate power levels.”
Technical Method: “Uses light based energy delivered to and or through the skin to effect change in the tissue that results in the reduction of wrinkles.”
Target Area: “Mostly intended to be used on the human face, голова, and neck.”
Источник: FDA Product Classification Database, Product Code OHS.
This is the FDA’s own description of the device category — independent confirmation that LED light therapy masks of this type are recognized as legitimate medical devices for wrinkle reduction in the United States.
5. The Four International Photobiological Safety Standards Behind K250830
The FDA Product Code OHS lists four Recognized Consensus Standards that apply to this device category. K250830 was reviewed in the context of these standards:
| FDA Recognition # | Стандартный | Объем |
|---|---|---|
| 12-102 | ANSI/IES RP-27.2-00 / R17 | Photobiological Safety for Lamps and Lamp Systems — Measurement Techniques |
| 12-249 | МЭК 62471 First Edition (2006-07) | Photobiological Safety of Lamps and Lamp Systems (international standard) |
| 12-297 | ANSI/IES RP-27.1-2015 | Photobiological Safety for Lamps and Lamp Systems — General Requirements |
| 12-321 | ANSI/IES RP-27.3-17 | Photobiological Safety for Lamps — Risk Group Classification and Labeling |
These four standards together cover:
- How light output should be measured (RP-27.2)
- The internationally accepted threshold limits for safe optical radiation (МЭК 62471)
- The general safety framework for lamp systems (RP-27.1)
- The risk-group classification and labeling rules that determine consumer safety (RP-27.3)
🌐 Source: FDA Product Classification page for OHS — Recognized Consensus Standards section.
6. What This FDA Clearance Means for B2B Buyers, Владельцы брендов, and Distributors
If you are a brand owner, распределитель, розничный торговец, or beauty-tech reseller evaluating LED light therapy masks, а K250830 clearance has four practical implications:
① United States market access.
А 510(k) clearance is the standard regulatory pathway required to legally market a Class II medical device in the U.S. K250830 is on the public FDA record and can be cited in your own product listings, упаковка, and retailer onboarding documents.
② Substantial Equivalence (SESE) determination.
The FDA’s decision of “Substantially Equivalent” means the device has been formally compared against legally marketed predicate devices and judged equivalent in safety and effectiveness for the cleared indications. This is the strongest possible 510(k) determination outcome.
③ Reviewed by FDA’s surgical device division — not the consumer products office.
K250830 was reviewed by the Division of General Surgery Devices (DHT4A) within the Office of Surgical and Infection Control Devices (OHT4) — the same division that reviews surgical lasers and dermatology equipment. This is a meaningful distinction from cosmetic-grade devices.
④ A foundation for your own brand’s regulatory file.
Because K250830 is held by the manufacturer (Компания Shenzhen Sungrow LED Technology Co., ООО.), private-label and OEM partners working with the manufacturer can reference this 510(k) clearance in their own documentation packages, subject to standard 21 CFR Part 807 listing and labeling requirements.
7. How to Independently Verify K250830
You do not need to take our word for it. Anyone can verify this clearance in less than 60 секунды:
Шаг 1. Visit the FDA 510(k) База данных предмаркетинговых уведомлений: 🔗(FDA Link)
Шаг 2. In the “510(k) Number” field, enter: K250830
Шаг 3. Confirm the following information matches:
- Applicant: Компания Shenzhen Sungrow LED Technology Co., ООО.
- Decision: Substantially Equivalent
- Decision Date: 06/09/2025
- Product Code: OHS
Шаг 4. Click “Summary” to download the public 510(k) Summary document, or click on the cleared device name to view the full record.
📌 Pro tip for legal/compliance teams: The Clearance Letter PDF and the database entry together constitute the primary evidence of FDA clearance. Both should be archived in your supplier qualification file.
8. About the Manufacturer
Компания Shenzhen Sungrow LED Technology Co., ООО. is the FDA-listed applicant of record for K250830. The company is headquartered in the Guangming High-Tech Industrial Park, Шэньчжэнь, Китай, and specializes in LED-based photobiomodulation devices for the beauty and wellness industry.
Wakelife is the company’s beauty-focused brand line, dedicated to bringing professionally-engineered LED light therapy products to global consumers and B2B partners.
Часто задаваемые вопросы
Is “FDA 510(k) cleared” the same as “FDA approved”?
Нет. “FDA cleared” via the 510(k) pathway means the device has been determined Substantially Equivalent to a legally marketed predicate device and may be marketed in the U.S. “FDA approved” is the term reserved for products that go through the more rigorous PMA (Premarket Approval) процесс, typically Class III high-risk devices. Most LED light therapy masks on the U.S. market are 510(k) очищен, not approved.
Does K250830 cover all 13 models equally?
Да. The Clearance Letter explicitly lists all 13 model designations (G15, G15p, Г15К, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) under the same 510(k) прозрачный.
Can I make claims about anti-aging, гиперпигментация, or pain relief based on K250830?
Нет. The FDA-cleared indications are limited to (а) full-face wrinkle treatment via red, желтый, or red+infrared light, и (b) mild-to-moderate inflammatory acne treatment via blue or mixed (red+blue+infrared) свет. Claims beyond these indications are not covered by K250830.
Is the device classified as a laser?
The regulation name (21 CFR 878.4810) historically covered laser surgical instruments and now also covers LED-based light therapy devices used for the same indications. The product itself uses LED light sources, not laser sources.
Where can the FDA Clearance Letter be downloaded?
The official PDF Clearance Letter signed by the FDA on June 9, 2025 is available on this page, and on the FDA’s own database under K250830.
Заключение
K250830 is a matter of public record. It confirms that the Светодиодная светотерапевтическая маска manufactured by Компания Shenzhen Sungrow LED Technology Co., ООО. — covering 13 модели including those marketed under the Wakelife brand — has received FDA 510(k) прозрачный as a Class II Over-The-Counter medical device для full-face wrinkle и mild-to-moderate inflammatory acne treatment.
По вопросам партнерства, OEM/ODM-программы, or to request the full regulatory documentation package, please contact our team.
Looking for an FDA-cleared LED light therapy mask partner?
Wakelife (Компания Shenzhen Sungrow LED Technology Co., ООО) is now accepting B2B inquiries for our K250830-cleared product line. Whether you are a brand looking to private-label, a distributor entering the U.S. рынок, or a retailer adding LED therapy to your category — we can support your compliance and supply chain requirements.
