|
Device | FRESHLOOK UV (PHEMFILCON A) SPHERICAL SOFT CONTACT LENSES FOR EXTENDED WEAR |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P830037 |
Supplement Number | S053 |
Date Received | 09/23/2011 |
Decision Date | 02/07/2012 |
Withdrawal Date
|
02/27/2019 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE USE THE NEW PHOENIX VT PRINT PADS USED TO TRANSFER INKS ONTO THE LENS SURFACE AND FOR THE ADDITION OF A PRE-CONDITIONING STEP FOR OPTIMAL INK ADHESION ONTO THE LENSES WHEN THE NEW PRINT PAD IS UTILIZED. |