EnergyLounger
EnergyLounger TY-01 is a recliner-like device with 1,260 LED lights and two mode-selection buttons. The FDA summary describes three working modes selected by the user. The filing identifies…
EnergyLounger TY-01 is a recliner-like device with 1,260 LED lights and two mode-selection buttons. The FDA summary describes three working modes selected by the user.
The filing identifies visible and infrared light energy and lists LED wavelengths of 630 nm, 850 nm and 940 nm.
Listed Item
Mi is used to reduce the circumference of the hips, waist and thighs and is indicated for use as a non. invasive dermatological. M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment offull-face wrinkles. M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for thepurpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness.minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporaryrelaxation of muscles.
Mode Details
The indication form lists M1 for reducing circumference at the hips, waist and thighs and describes M2 as using visible and infrared energy for treatment. The FDA summary says the device automatically stops treatment.
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 | Shenzhen Kaiyan Medical Equipment 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 | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K241947 |
| Record published | 2025-06-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TY-01 | 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 |
|---|---|
| K254025 | 2026-06-16 |
| K252603 | 2026-01-28 |
| K252272 | 2025-10-09 |
| K251781 | 2025-09-04 |
| K251012 | 2025-08-14 |
| K250761 | 2025-07-11 |
| K250966 | 2025-06-25 |
| K250581 | 2025-05-30 |
| K250532 | 2025-05-22 |
| K241947 | 2025-03-03 |
| K242593 | 2025-02-14 |
| K241933 | 2024-09-27 |
| K240089 | 2024-04-10 |
| K233556 | 2024-01-04 |
| K232863 | 2023-12-13 |
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.