Home Home
 
Floaters, FDA:
Floater Types-Success Floater Types-Success
F.D.A. and Floaters F.D.A. and Floaters
 
Cost and Candidate:
Cost and Insurance Cost and Insurance
Candidate? Candidate?
Young Patients Young Patients
 
Laser Treatment:
Our Procedure Our Procedure
Before/After Photos Before/After Photos
Science Background Science Background
Patient Testimonials Patient Testimonials
Our Contributions Our Contributions
Why Few Doctors Why Few Doctors
 
Safety:
Benefits and Risks Benefits and Risks
Our Floater Study Our Floater Study
Protecting the retina Protecting the retina
Operative Permit Operative Permit
 
Our Equipment:
Our Laser Our Laser
Our Contact Lenses Our Contact Lenses
 
Other Treatment:
Vitrectomy Vitrectomy
 
More Information:
Our Book Our Book
Eleven Most Interesting Cases Eleven Most Interesting Cases
World literature listing World literature listing
Links Links
 
Seeing Dr. Karickhoff:
Exam. In Your City Exam. In Your City
You In Our Office You In Our Office
International Patients International Patients
Map, Airports, Airlines, Train, Motels, Subway Map, Airports, Airlines, Train, Motels, Subway
Fun In Falls Church Fun In Falls Church
Seeing Washington Seeing Washington
 
Your Surgeon:
Know Dr. Karickhoff - Beyond Floaters Know Dr. Karickhoff - Beyond Floaters
Audio Greeting from Dr. Karickhoff Audio Greeting from Dr. Karickhoff
Our Goals Our Goals
Our Laser Experience Our Laser Experience
Our Gallery Our Gallery
Our Firsts Our Firsts
 
Ocular Innovation:
Why Innovate? Why Innovate?
Dr. K's Unique Career in Innovation, Photos & his Curriculum Vitae Dr. K's Unique Career in Innovation, Photos & his Curriculum Vitae
Dr. K's Video On Innovation Basics Dr. K's Video On Innovation Basics
Ocular Innovation Awards Ocular Innovation Awards
Dr. K. on Advanced Innovation Tasks (for doctors) Dr. K. on Advanced Innovation Tasks (for doctors)
 
Contact Us Contact Us
 

U.S. FOOD AND DRUG ADMINISTRATION AND FLOATERS

Image

   For years YAG lasers have been used to treat vitreous floaters. However, the FDA had never taken a position specifically on floater treatment, and no data on floater treatment had ever been submitted to them.
   On March 11, 2002 Doctor Karickhoff submitted to the FDA a document (seven inches in height) that reviewed: manufacturing of the laser, the effect of the laser on floaters, all animal studies, all human studies and their world wide publications, Dr. Karickhoff's past cases, his research, his expertise, his instrument designs, etc.
   On March 20, 2002 the FDA informed Dr. Karickhoff that on the bases of his documents and after a physicist's review of the laser, the FDA had ruled that his  proposed study of laser treatment of vitreous opacities was a non-significant risk device study.  They further ruled that a special device exemption from the FDA to use a YAG laser in the study was not required.   After receiving these rulings, Dr. Karickhoff's formal study of laser treatment was begun and was completed three years later.  Even with these very positive FDA rulings, laser treatment of eye floaters should still be considered an off-label use of the YAG laser.