R11 Air
Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Beijing (2), Henan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Syntech Laser Co., Ltd. | Beijing | Beijing | Contract manufacturer | 5 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Zhengzhou PZ Laser Slim Technology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 6 |
| Shenzhen Light Tree Ventures Medical Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 6 |
| Shenzhen Suyzeko Limited | Shenzhen | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | KBL GmbH, Germany |
|---|---|
| FDA product code | OLI |
| Device type | Fat Reducing Low Level Laser |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5400 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K202955 |
| Record published | 2025-06-25 |
| Record revised | 2025-07-03 (version 2) |
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 |
|---|---|---|
| R11-s-2848r1-1188i1 UP 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Led Light Phototherapy Bed | Shenzhen Suyzeko Limited | 2 |
| Erchonia Zerona VZ8 | Erchonia Corporation | 1 |
| Emerald | Erchonia Corporation | 1 |
| Zerona 2.0 | Erchonia Corporation | 1 |
| Verju | Erchonia Corporation | 1 |
| Erchonia CLX | Erchonia Corporation | 1 |
| Zerona Z6 | Erchonia Corporation | 1 |
| Photonica Professional | Photonica USA LLC | 1 |
| UltraSlim Digital | Photonica USA LLC | 1 |
| Erchonia Zerona Z-Bed | Erchonia Corporation | 1 |
| Zerona AD | Erchonia Corporation | 1 |
| UltraSmooth Digital | Photonica USA LLC | 1 |
Showing 12 of 13. All products under Fat Reducing Low Level Laser
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.