eCO2 3D

The eCO2 3D is a laser surgical system using a 10.6 micrometer CO2 laser delivered through an articulated arm for dermatological and surgical procedures. It performs ablation, resurfacing, coagulation, excision, and incision of soft tissue for treating wrinkles, scars, lesions, and various skin conditions in dermatology, plastic surgery, general surgery, and podiatry.

The eCO2 3D uses a 10.6 micrometer CO2 laser with an articulated arm handpiece delivery system, similar to the predicate eCO2 Plus. Key differences include a 520nm green aiming beam (vs. 637nm on predicate), maximum 40W power output, 10.1-inch touch LCD interface, and multiple interchangeable handpiece tips that allow users to vary beam spot size and energy shaping during delivery.

IEC 60601-1 (medical electrical equipment safety), IEC 60601-2-22 (laser equipment safety), IEC 60825-1 (laser product classification), EN ISO 14971 (risk management), IEC 62366-1 (usability engineering), ISO 10993 series (biocompatibility), ISO 15223-1 (device labeling symbols), and ISO 11607 (sterile barrier packaging).

The eCO2 3D meets substantial equivalence because its technological specifications are the same or a subset of the predicate eCO2 Plus, sharing identical laser wavelength, transmission medium, delivery method, and safety classification. The additional interchangeable handpiece tips provide users with more options for shaping energy delivery—a feature already present in the reference device Finexel—without changing the fundamental operating principles or safety profile. The indications for use are identical to the predicate device.