LED Lollipop
S2197 LED Lollipop
235manufacturers in China registered for this device type
1catalogue number
9recalls on this code
Who Else Makes It
Concentrated in Guangdong (145), Zhejiang (21), Jiangsu (9). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Dongguan Tutamen Metalwork Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 12 |
| Gymmax Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Wellbeing Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Wuxi Jiajian Medical Instrument Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 6 |
| Shenzhen Sungpo HI-Tech Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Shenzhen Allbeauty Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
Showing 12 of 235. All 235 manufacturers in China registered for Lamp, Infrared, Therapeutic Heating
Record
| Listed by | Thor Photomedicine Ltd, United Kingdom |
|---|---|
| FDA product code | ILY |
| Device type | Lamp, Infrared, Therapeutic Heating |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5500 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K033923 |
| Record published | 2021-10-01 |
| Record revised | 2026-04-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lescolton | Shenzhen Lescolton Medical Equipment Co., Ltd. | 50 |
| HealthLight | Healthlight LLC | 40 |
| Therapy Light | E.shine Lighting Co., Limited | 32 |
| Phoenix Thera-Lase system | Phoenix Thera-Lase Systems, LLC | 32 |
| AisQueen | Shenzhen AIS Queen Medical Technology Co., Ltd. | 30 |
| LED RED Light Therapy Panel | Shenzhen RedV Medical Equipment Co., Ltd. | 27 |
| Chattanooga | DJO, LLC | 25 |
| Lumix Ultra/Plus | Fisioline SRL | 22 |
| UTK | UTK Technology(Shenzhen)Limited | 21 |
| LZ30 | Avant Wellness Systems Inc | 21 |
| LS Pro Systems | Wellness Without Limits LLC | 21 |
| Dimed | Wuhan Dimed Laser Technology Co., Ltd. | 20 |
Showing 12 of 536. All products under Lamp, Infrared, Therapeutic Heating
Recalls
9 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-07-24 | Class II | Process control | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift. | 1 unit |
| 2025-07-24 | Class II | Process control | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift. | 80 units (66 US, 14 OUS) |
| 2025-07-24 | Class II | Process control | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift. | 2 units (1 US, 1 OUS) |
| 2025-07-24 | Class II | Process control | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift. | 55 units (41 US, 14 OUS) |
| 2023-11-20 | Class II | Component design/selection | One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy | 61 (41 US; 20 OUS) |
| 2022-09-13 | Class II | Device Design | Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. | 6 |
| 2022-09-13 | Class II | Device Design | Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. | 26 |
| 2022-09-13 | Class II | Device Design | Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. | 19 |
| 2022-09-13 | Class II | Device Design | Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. | 26 |
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.