• 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 | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSOFLENS66(TM)
Classification Namelenses, soft contact, extended wear
Generic Namealphafilcon a visibility tinted contact lenses
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP960022
Date Received06/28/1996
Decision Date12/16/1996
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 97M-0183
Notice Date 05/22/1997
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the bausch & lomb(r) soflens66(tm) (alphafilcon a) visibility tinted contact lens for extended wear.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 
-
-