Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHYPERION LTK SYSTEM
Classification Namelaser, ophthalmic
Generic Nameophthalmic medical laser system
Regulation Number886.4390
ApplicantSUNRISE TECHNOLOGIES, INC.
PMA NumberP990078
Supplement NumberS001
Date Received11/09/2000
Decision Date12/11/2000
Product Code
HQF[ Registered Establishments with HQF ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the warning section of the labeling.
-
-