Is Laser Spine Institute Fda Approved
The holmium laser was fda approved for use in orthopedics and the spine in the 1980 s and the laser is medicare approved to treat painful lumbar discs as an outpatient.
Is laser spine institute fda approved. About laser spine institute. Its like buying a car but getting charged 30k for floor mats. Well ladies and gentlemen you ve been had. The bonati spine institute is the birthplace of the world famous bonati spine procedures.
Laser spine s chief operating officer for some years was st. Laser products designed and promoted for the production of laser light shows displays advertising etc. Are demonstration laser products subject to the requirements of 21 cfr 1040 11 c. And getting medicare approval for a surgical procedure is no small feat.
The highly skilled spine surgeons and specialists at the bonati spine institute possess credentials and experience. The fda has not approved most stem cell treatments and has said it considers many of them illegal. However for this additional service patients receive and additional bill of up to 30 000. Basically laser spine surgeons perform the same operation any other spine surgeon performs with the addition of a laser at the end of the procedure.
Louis cincinnati scottsdale and tampa florida where it is headquartered. The laser spine institute. Currently laser spine institute specializes in general practice neurological surgery orthopedic surgery orthopedic surgery of spine other specialty pain management physical medicine rehabilitation and pain medicine with 9 physicians. The company had four remaining surgery centers in st.
Laser spine institute is a group practice with 1 location. Amo manufacturing usa llc. If you have been referred to us by your primary care doctor our spine surgeons are fully qualified to provide the best neurological services for your. Approval number and date device or consumer information instructions.
P930016 s053 june 15 2018. It was the first surgical center to provide outpatient spine surgery and to gain approval by the fda for the use of a laser in spine surgery. The laser spine institute which once ran a nationwide chain of surgery centers that specialized in minimally invasive spinal procedures has abruptly ceased operations due to financial problems. There isn t a single peer reviewed article in any major medical journal on laser spine surgery not a single shred of evidence to support it no fda approved clinical trial no randomized controlled trials showing it is even superior to aspirin let alone other types of surgery.
Laser spine surgery is not approved.