Zerona Z6
AESTHETIC - Floor Model Low Level Laser -- 6 diodes 635nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference/Fat
6manufacturers in China registered for this device type
1catalogue number
16510(k) clearances naming this product code
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 | Erchonia Corporation, United States |
|---|---|
| FDA product code | OLI |
| Device type | Fat Reducing Low Level Laser |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5400 |
| Establishment | Remanufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K162578 |
| Record published | 2016-09-24 |
| Record revised | 2026-07-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SHR | 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 |
| Photonica Professional | Photonica USA LLC | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252574 | 2025-12-15 |
| K243811 | 2025-01-10 |
| K231474 | 2023-07-21 |
| K220519 | 2022-03-24 |
| K192544 | 2020-01-13 |
| K162578 | 2016-12-16 |
| K150446 | 2015-05-21 |
| K143007 | 2015-01-15 |
| K142042 | 2014-10-21 |
| K133718 | 2014-05-12 |
| K130922 | 2013-05-17 |
| K123237 | 2013-01-25 |
| K121690 | 2012-08-23 |
| K121695 | 2012-08-23 |
| K120257 | 2012-05-14 |
| DEN090008 | 2010-08-24 |
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.