Sunglor
SG-FSM is a named subject model of the Sunglor LED Light Therapy Device. The packet links the exact model to its filing. The SG-FSM is an over-the-counter device intended for facial and…
SG-FSM is a named subject model of the Sunglor LED Light Therapy Device. The packet links the exact model to its filing.
The SG-FSM is an over-the-counter device intended for facial and décolletage wrinkles, with red light or red plus infrared light.
Listed Item
LED Light Therapy Device
Model Use and Configuration
The comparison table lists SG-FSM for face and décolletage, with home use and over-the-counter use.
The device uses an internal rechargeable lithium battery. The packet says it cannot be used while connected for charging.
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 | Sunglor Technology Co., Ltd., China |
|---|---|
| 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, Manufacturer |
| 510(k) | K253073 |
| Record published | 2026-06-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SG-FSM | In distribution | |
| SG-NK | In distribution | |
| SG-CT | In distribution | |
| SG-FM | In distribution | |
| SG-FE | 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 |
|---|---|
| K253086 | 2025-12-19 |
| K253073 | 2025-11-19 |
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.