Innovation Pharmaceuticals Inc (IPIX)

[williamssc]

Device Description: Page 2 of 4.
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.
Indications for Use:

The Fibers are indicated for use in general surgical applications for incision, excision,
vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in
open or closed endoscopic applications where incision, excision, tissue dissection, excision of
external tumors and lesions, complete or partial resection of internal organs, tumors or lesions,
tissue vaporization, hemostasis and or coagulation may be indicated.

The BeaMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be
used in contact and non-contact mode and are indicated for use in general surgery, urology,
gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery,
ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial
vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the
mentioned intended uses and using an SMA 905 connector.

https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232769.pdf