"So we have approval already."
But for what? From your link.....
"Device Description:
The BeaMed Laser Surgery Fibers are sterile, single use, laser delivery devices intended for
medical applications in various fields of laser surgery. They are intended to deliver energy to
soft tissue in contact and non-contact mode during various surgical applications, including via
endoscopes and cytoscopes. The fibers are designed to transmit energy from the laser system
to the treatment site, as well as to transmit a low power laser aiming beam to assist in the
visibilty of the target tissue."
Approval to market the fibers that deliver the energy.
I'll let you or someone else explain how critical that is (it obviously isn't NEW).
There's a machine (old technology) that creates/develops the energy, there's software that drives the machine (the big promise...the potential purportedly under development) and there's the fiber (old technology) that carries the energy to the repair site.
"So we have approval already".......to sell an accessory.
Not evidence of any innovation at all.
Seek help and correct me if I'm wrong.