Photonica Professional
Photonica Professional, Red Light (635 nm)
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 | Photonica USA LLC, United States |
|---|---|
| FDA product code | OLI |
| Device type | Fat Reducing Low Level Laser |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-12-21 |
| Record revised | 2026-07-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60001 | 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 |
| UltraSlim Digital | Photonica USA LLC | 1 |
| R11 Air | KBL GmbH | 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
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. 3 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-05-06 | Class II | No Marketing Application | Marketing without marketing clearance or approval. | 235 Total | 2015-06-24 |
| 2014-05-06 | Class II | No Marketing Application | Marketing without marketing clearance or approval. | 235 Total | 2015-06-24 |
| 2014-05-06 | Class II | No Marketing Application | Marketing without marketing clearance or approval. | 235 Total | 2015-06-24 |
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.