10PL
The FDA filing identifies model 10PL as a photo therapy unit that uses filtered intense pulsed light in dermatology applications. Its stated intended use is surgical and aesthetic…
The FDA filing identifies model 10PL as a photo therapy unit that uses filtered intense pulsed light in dermatology applications.
Its stated intended use is surgical and aesthetic dermatology applications using filtered Intense Pulsed Light.
Listed Item
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect-10PL Handpiece
Stated Use and Limits
The filing lists melasma treatment at 415 to 950 nm for skin types I to IV; melasma and rosacea at 570 to 950 nm; and rosacea and port wine stains at 590 to 950 nm.
Who Else Makes It
Concentrated in Guangdong (11), Beijing (10), Hebei (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen Solex High-Tech Industries Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Shen Zhen HanShine Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Beijing Starlight Science & Technology Development Co., Ltd. | Beijing | Beijing | Contract manufacturer | 4 |
| Guangzhou Telefield Limited | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Guangdong Fuqiang Beauty Equipment Co., Limited | Qingyuan | Guangdong | Manufacturer | 13 |
| Shenzhen Perfect Idea Technology Limited | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Beijing Adss Development Co., Ltd. | Beijing | Beijing | Manufacturer | 8 |
| Rejuva Fresh LLC | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 31. All 31 manufacturers in China registered for Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Record
| Listed by | Tentech Inc., South Korea |
|---|---|
| FDA product code | ONF |
| Device type | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K220794 |
| Record published | 2024-06-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10PL-H/P | In distribution | |
| 10PL-Body | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Isolaz | Solta Medical, Inc. | 21 |
| Quantaforte | Quanta System Spa | 8 |
| Apolomed | Shanghai Apolo Medical Technology Co., Ltd. | 7 |
| Me | Iluminage Ltd | 7 |
| Remington | Spectrum Brands, Inc. | 6 |
| Silk’n | Home Skinovations, Ltd. | 6 |
| Huamei | Shandong Huamei Technology Co., Ltd. | 6 |
| Remington Products | Spectrum Brands, Inc. | 6 |
| Intense Pulsed Light (IPL) System | Shenzhen Fansizhe Science AND Technology Co., Ltd. | 5 |
| Iluminage | Iluminage Ltd | 5 |
| Luma Rx | Spectrum Brands, Inc. | 5 |
| Silk’n | Silkn Beauty Ltd. | 4 |
Showing 12 of 133. All products under Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220794 | 2022-11-10 |
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.