Shark CryoGlow
Shark CryoGlow is an over-the-counter facial LED mask for fine lines, wrinkles and mild to moderate inflammatory acne. It uses red and infrared light for wrinkles and combinations of red,…
Shark CryoGlow is an over-the-counter facial LED mask for fine lines, wrinkles and mild to moderate inflammatory acne. It uses red and infrared light for wrinkles and combinations of red, blue and infrared light for acne. The molded mask is worn over the face during a selected treatment routine.
An attached controller selects the light routine. Built-in under-eye cooling pads use thermoelectric cooling and fans, and cooling can be switched off during a light session or used separately. Optional clip-on pads help adjust the fit beneath the eyes.
Listed Item
The Shark CryoGlow Mask is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles. The Model Number is FW312.
Power and Eye Protection
The mask must be charged before use. Built-in silicone shields help protect the eyes, while automatic shutoff and dimming features control light delivery when the mask is moved away from the 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 | 2025-09-18 |
| Record revised | 2026-07-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FW312 | In distribution | |
| FW302 | In distribution | |
| FW312 | In distribution | |
| FW312PL | In distribution | |
| FW322 | In distribution | |
| FW302PL | In distribution | |
| FW332COPL | 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 |
| 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 |
| Sunglor | Sunglor Technology Co., Ltd. | 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.