Shark
CryoGlow is an LED mask. The filing states that its red and infrared light is intended for fine lines and wrinkles, while red, blue and infrared light is listed for mild-to-moderate…
CryoGlow is an LED mask. The filing states that its red and infrared light is intended for fine lines and wrinkles, while red, blue and infrared light is listed for mild-to-moderate inflammatory acne.
The mask’s under-eye cooling function uses fans and thermoelectric elements to cool built-in pads resting on skin beneath the eyes. The filing says the cooling function is intended to refresh, invigorate or soothe skin.
Listed Item
The CryoGlow is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
Built-in Features
Silicone eye shields are built into the mask. The filing also identifies automatic shutoff and LED dimming when the mask is away from the user’s face.
Who Else Makes It
Concentrated in Guangdong (57), Fujian (4), Zhejiang (2). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Shenzhen Huayan E-Commerce Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Xiamen Solex High-Tech Industries Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Zhangzhou Easepal Medical Science AND Technology Co., Ltd. | Zhangzhou | Fujian | Contract manufacturer | 8 |
| Gymmax Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Xiangzhida Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shenzhen Zowee Smart Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Foshan Shiding Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Allbeauty Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Ningbo Yimei Nikko-Seiki Manufacture Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 3 |
| Shenzhen Azure Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Showing 12 of 67. All 67 manufacturers in China registered for Light Based Over The Counter Wrinkle Reduction
Record
| Listed by | Sharkninja Operating LLC, United States |
|---|---|
| FDA product code | OHS |
| Device type | Light Based Over The Counter Wrinkle Reduction |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K242796 |
| Record published | 2025-01-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CryoGlow | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LED Light Therapy Mask | Shenzhen Rainbow Technology Co., Ltd. | 16 |
| Light Based Over The Counter Wrinkle Reduction | Shenzhen Sungrow LED Technology Co., Ltd. | 13 |
| reVive Light Therapy® | LED Technologies, Inc. | 10 |
| PMD | Dongguan Hunter Electronic Technology Co., Ltd. | 10 |
| ACE-TEC | Guangdong Ace-Tec Co., Ltd. | 9 |
| Conair | Conair LLC. | 9 |
| Shark CryoGlow | Sharkninja Operating LLC | 7 |
| Celluma | Biophotas, Inc. | 6 |
| Liyoutong | Shenzhen Liyoutong Technology Co., Ltd. | 6 |
| Light Based Over The Counter Wrinkle Reduction | Guangdong Newdermo Biotech Co., Ltd. | 6 |
| Dr Dennis Gross Skincare | LED Technologies, Inc. | 6 |
| NuFACE | Nuface | 5 |
Showing 12 of 157. All products under Light Based Over The Counter Wrinkle Reduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242796 | 2024-11-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.