Search Results
Found 1 results
510(k) Data Aggregation
(123 days)
The Erchonia CLX is indicated for use as a non-invasive dermatological aesthetic treatment for improving the appearance of submental fat.
The Erchonia® CLX Laser is intended for patients seeking a noninvasive, non-thermal alternative for fat reduction in the submental (chin) area, allowing them to resume daily activities without the downtime associated with surgery, pain, wounds, or compression garments. The CLX Laser delivers non-thermal, low-level laser energy that induces temporary pore in adipocytes, allowing fat and lipids to be released into the interstitial space, where they are naturally processed by the body's detoxification pathways. The CLX is built on the proven clinical foundation of previous Erchonia low-level laser devices, including the Violet ZERONA® Z8, ZERONA®, ZERONA®-AD, ZERONA® Z6 OTC, Verju, and Emerald.
The CLX Laser is a handheld device that incorporates two semiconductor diodes emitting green (520 nm ±10 nm) and violet (405 nm ±10 nm) light. Both diodes emit non-thermal light at 7.5 mW (±0.50 mW) output, classified as Class 2 laser sources under IEC. The non-thermal light output from each diode is collected and directed through a proprietary, patented lens and then shaped into a uniform line beam by an internal refractor. The device is powered by a rechargeable internal battery and supplied with an inductive charging base driven by an external Class II medical-grade power supply. The device's control software, embedded in a RAM chip on the printed circuit board, manages all user interface operations. The graphical user interface (GUI) and touch-screen prompts allow for intuitive device control. The software has been developed and validated in accordance with the applicable FDA and ISO requirements for software design and validation.
N/A
Ask a specific question about this device
Page 1 of 1