Erchonia CLX
Erchonia CLX is a handheld low-level laser for noninvasive aesthetic treatment to improve the appearance of submental fat. Two semiconductor diodes deliver nonthermal green and violet light…
Erchonia CLX is a handheld low-level laser for noninvasive aesthetic treatment to improve the appearance of submental fat. Two semiconductor diodes deliver nonthermal green and violet light to the chin region.
The green diode emits at 520 ± 10 nm and the violet diode at 405 ± 10 nm. Each has a nominal output of 7.5 ± 0.50 mW, shaped into a uniform line beam by internal optics.
Listed Item
AESTHETIC – Handheld Low Level Laser – 2 diodes 520nm & 405 nm 7.5 mW – includes induction charger – IFU dermatological aesthetic treatment for improving the appearance of submental fat
Power and Controls
A rechargeable internal battery powers the handpiece, and an inductive charging base connects to a medical-grade power supply. Touchscreen prompts provide control. The specified treatment pattern is 15 minutes per area, twice weekly for four weeks.
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) | K252574 |
| Record published | 2026-07-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CFL | 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 |
| 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.