Erchonia Zerona VZ8
Erchonia Zerona VZ8 is a low-level laser system intended for noninvasive aesthetic reduction of body circumference. Eight adjustable applicator heads deliver violet light toward the…
Erchonia Zerona VZ8 is a low-level laser system intended for noninvasive aesthetic reduction of body circumference. Eight adjustable applicator heads deliver violet light toward the selected treatment areas.
Each diode emits around 405 nm at a measured output of 23 mW, with a tolerance of 2 mW. Internal optics collect the light and pass it through a lens and line refractor.
Listed Item
AESTHETIC – Floor Model Low Level Laser — 8 diodes 405nm 25mW – OTC (Non-prescriptive) – IFU Reduction Circumference/Fat
Optical Delivery
The adjustable arms position the heads a short distance from the treatment area rather than in contact with the skin. The system’s control software manages the laser operation using its specified treatment setup. The eight-diode arrangement distributes the individual light outputs across the selected areas.
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) | K243811 |
| Record published | 2025-02-25 |
| Record revised | 2026-07-21 (version 2) |
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 |
|---|---|---|
| VZ8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Led Light Phototherapy Bed | Shenzhen Suyzeko Limited | 2 |
| 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 |
| 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.