Sculpt I.Q.
Laser protective goggles for spectacle wearers
235manufacturers in China registered for this device type
13catalogue numbers in this listing
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 | Dentsply Sirona Orthodontics Inc., United States |
|---|---|
| FDA product code | ILY |
| Device type | Lamp, Infrared, Therapeutic Heating |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2018-03-14 |
| Record revised | 2024-03-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2018-04-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6659101G | Withdrawn | ||
| 6659192G | 5 | Withdrawn | |
| 6659556 | Withdrawn | ||
| 6659226G | Withdrawn | ||
| 6659242G | Withdrawn | ||
| 6659184 | Withdrawn | ||
| 6659556G | Withdrawn | ||
| 6659283G | 25 | Withdrawn | |
| 6659234 | Withdrawn | ||
| 6659291 | 25 | Withdrawn | |
| 6659291G | 25 | Withdrawn | |
| 6659309G | Withdrawn | ||
| 6659218G | Withdrawn |
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
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.