Короткий ответ: The FDA’s public record identifies K250830 as a Traditional 510(k) for an LED Light Therapy Mask, submitted by Shenzhen Sungrow LED Technology Co., ООО. FDA issued a substantially equivalent decision on June 9, 2025. The record names 13 model designations and lists family-level OTC light-mode and indication statements for full-face wrinkles or mild-to-moderate inflammatory acne. It does not provide a model-by-model light-mode matrix. K250830 is a clearance—not FDA approval, a factory-wide certificate, or permission to transfer the same claims to unrelated devices.
This page is the model- and claim-scope record for K250830. For the broader difference between establishment registration, device listing, 510(k) прозрачный, and approval, использовать Зарегистрировано FDA против FDA 510(k) Cleared LED Face Masks guide.
What Does the FDA Database Show for K250830?
| Поле | FDA public record |
|---|---|
| 510(k) число | K250830 |
| Device name | Светодиодная светотерапевтическая маска |
| Заявитель | Шэньчжэньская компания Sungrow Led Technology Co., ООО. |
| Regulation number | 21 CFR 878.4810 |
| Product codes | ОХС; subsequent product code OLP |
| Regulatory class | Класс II |
| Submission type | Традиционный 510(k) |
| Date received | Маршировать 19, 2025 |
| Decision date | Июнь 9, 2025 |
| Решение | По существу эквивалентен (НЕПРАВИЛЬНЫЙ) |
| Third-party review | Нет |
The decision means FDA found the submitted device substantially equivalent to legally marketed predicate devices for the indications stated in the enclosure. It does not denote official FDA approval. The distinction matters because 21 CFR 807.97 states that representing a substantial-equivalence determination as official approval is misleading and constitutes misbranding.
Which Model Designations Are Named in K250830?
The FDA database and the K250830 clearance letter name these 13 Обозначения моделей:
| Covered model designations |
|---|
| G15, G15p, Г15К, G11P, G11, G10, G13, G14, G17, ОБЩИЙ, ПРАНА, Chin2Chest, BBL-МАСКА ДЛЯ ЛИЦА |
This is the public model-designation boundary; it does not by itself prove that every product or configuration using a listed designation matches the cleared device. It does not cover a model merely because it is made by the same factory, uses similar wavelengths, or belongs to another Wakelife product category. In particular, K250830 should not be presented as clearance for red-light panels, терапевтические ремни, устройства для роста волос, глазные устройства, pet devices, UVB products, or any model not named in the record.
What Indications for Use Are Cleared?
The Indications for Use enclosure in the FDA letter lists the following family-level OTC light-mode and indication statements for the named LED Light Therapy Mask family:
| Light mode stated in K250830 | Сброшенная индикация |
|---|---|
| Красный свет | Лечение морщин по всему лицу |
| Желтый свет | Лечение морщин по всему лицу |
| Красный + инфракрасный свет | Лечение морщин по всему лицу |
| Синий свет | Treatment of mild-to-moderate inflammatory acne |
| Смешанный свет: красный + синий + инфракрасный | Treatment of mild-to-moderate inflammatory acne |
The public Form 3881 does not provide a model-by-model light-mode matrix. A designation being named does not by itself show that the model includes every listed mode. Verify the selected model’s actual modes and controlled labeling, and pair only an available mode with its corresponding indication.
A model designation—including a name that appears to describe a treatment area—does not expand the cleared treatment area or indication. Confirm the actual treatment area and claims in the controlled labeling rather than inferring them from the model name.
These are regulatory scope statements, not universal claims about every red, желтый, синий, or infrared device. A wavelength or color appearing in another product does not transfer K250830’s indications to that product.
The clearance does not support claims for pain relief, заживление ран, рост волос, лечение шрамов, розацеа, гиперпигментация, спать, восстановление мышц, or other uses not stated in the K250830 enclosure.
What Does K250830 Not Prove?
K250830 does not prove that:
- FDA approved or endorsed Wakelife, Шэньчжэнь Сангроу, or any customer brand;
- every product made at the applicant’s factory is FDA-cleared;
- every mode or marketing phrase used on a current product page appears in the cleared labeling;
- a modified private-label configuration remains within scope without review;
- FDA tested every production unit or determined compliance with every other federal requirement;
- clearance for an LED face-mask family can be used for panels or another device category.
The FDA letter itself says that an SE determination does not mean FDA has determined compliance with all other requirements. Registration and listing, маркировка, quality-system requirements, medical-device reporting, UDI obligations, and other applicable controls continue after clearance.
Can a Private-Label Brand Use a Manufacturer’s 510(k)?
A distributor does not automatically need a new 510(k) only because the same cleared device is sold under the distributor’s company name. FDA 510(k) Часто задаваемые вопросы says the manufacturer should submit the 510(k), and the label must accurately disclose the relationship when the named company is not the manufacturer—for example, Manufactured for или Distributed by.
That answer does not make private labeling automatic in every project. Before relying on K250830, the manufacturer, распределитель, and their regulatory advisers should confirm that the exact device configuration, предполагаемое использование, light modes, маркировка, инструкции, аксессуары, software, and claims remain within the cleared scope. FDA explains that a different intended use, and some significant device changes, can require a new 510(k).
How Should an OEM Buyer Verify K250830?
Use this sequence before approving packaging, marketplace listings, distributor files, or medical claims:
- Open the FDA K250830 database record and confirm the applicant, имя устройства, product codes, decision, and date.
- Open the official clearance letter and Indications for Use. Confirm that your selected model designation is named. Do not infer from the public document that every named model includes every listed mode.
- Use the 510(k) holder’s controlled device and labeling records to confirm the selected model’s actual modes. Compare the exact configuration with the cleared version—including hardware, wavelengths and modes, controller or software, аксессуары, зона лечения, инструкции, предупреждения, and labeling—and pair the planned claim only with a mode the selected configuration actually has.
- Confirm how the private-label relationship will appear on the label and who holds each post-market responsibility.
- Escalate any design, software, intended-use, or claim change for documented regulatory review before treating the existing clearance as applicable.
Do not rely on an FDA badge, cropped screenshot, certificate-style graphic, or supplier statement by itself. The database entry and FDA letter are the public starting points. A documented comparison against the 510(k) holder’s controlled device and labeling records is needed before the responsible parties determine whether the record applies to a project.
What Should Buyers Request From Wakelife?
For a K250830-scope review, send Wakelife:
- your selected model designation;
- target market and sales channel;
- proposed brand name and label role;
- intended use and exact consumer-facing claims;
- planned hardware, software, accessory, упаковка, or IFU changes;
- required launch date.
Ask Wakelife which controlled labeling and technical documents are available for the selected model and proposed configuration. Availability and scope must be confirmed for the specific project; this is not blanket authorization to use K250830 or reproduce its claims.
For supplier-level terminology and red flags, continue to the Зарегистрировано FDA против FDA 510(k) Cleared LED Face Masks guide. For the wider market-authorization and test-document map, использовать Руководство по сертификации устройств для светодиодной терапии.
Request a K250830-Scope Review
Provide the selected model designation, proposed configuration, intended claims, целевой рынок, and planned labeling changes. Wakelife can confirm which controlled labeling and technical documents are available for review. K250830 applicability must be assessed for the exact device and configuration; a model name or private-label relationship alone does not establish clearance scope.
Часто задаваемые вопросы
Is K250830 FDA approved?
Нет. K250830 received an FDA substantially equivalent decision through the 510(k) путь. The correct description is FDA 510(k)-cleared, нет FDA-approved.
Does K250830 cover every Wakelife LED mask?
Нет. It covers the 13 model designations named in the FDA record. A model not named there requires a separate scope check, even if it looks similar or is made by the same manufacturer.
Does every named model have every listed light mode?
The public Form 3881 does not provide that model-by-model matrix. It lists the 13 model designations and separately maps specific light modes to indications. The selected model’s actual modes and controlled labeling must therefore be checked before applying a listed indication.
Does K250830 cover Wakelife red-light panels?
Нет. The FDA record is for the named LED Light Therapy Mask family. It should not be used as clearance for red-light panels or other unrelated device categories.
Discuss a K250830-Scope OEM Project
Evaluating a private-label LED mask for the U.S. рынок? Share your selected model designation, intended claims, proposed configuration, and labeling requirements with Wakelife. Our team can confirm which controlled labeling and technical documents are available for your specific project. Applicability of K250830 must be verified for the exact device and configuration.
Official Sources
| Нет. | Официальный источник |
|---|---|
| 1 | НАС. Управление по контролю за продуктами и лекарствами. 510(k) Premarket Notification K250830. Public database record. |
| 2 | НАС. Управление по контролю за продуктами и лекарствами. K250830 Clearance Letter and Indications for Use. Decision dated June 9, 2025. |
| 3 | НАС. Управление по контролю за продуктами и лекарствами. Предмаркетинговое уведомление 510(k). |
| 4 | НАС. Управление по контролю за продуктами и лекарствами. 510(k) Часто задаваемые вопросы. |
| 5 | Electronic Code of Federal Regulations. 21 CFR 807.97: Misbranding by Reference to Premarket Notification. |
