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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP830037
Supplement NumberS047
Date Received10/25/2002
Decision Date11/26/2002
Withdrawal Date 02/27/2019
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL COLORANT TO BE USED IN THE COLORANT PROCESS AND A REVISION TO THE LABELING TO MOVE THE STATEMENT "THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE" FROM THE ACTIONS SECTION OF THE PACKAGE INSERT TO THE INDICATIONS SECTION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FRESHOOK TRADE NAME WITH THE FOLLOWING INDICATIONS: VISION CORRECTION SPHERICAL: FRESHLOOK SPHERICAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 2.0 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE. TORIC FRESHLOOK TORIC (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 6.0 DIOPTERS. THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE. THE LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR IN NOT-APHAKIC PERSONS FROM 1 TO 7 DAYS BETWEEN REMOVAL FOR CLEANING AN DISINFECTION OR DISPOSAL, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL OR FOR DAILY WEAR IN APHAKIC PERSONS. THE EYE CARE PROFESSIONAL MAY PRESCRIBE THE LENS IN EITHER THE SINGLE-USE DISPOSABLE WEAR OR FOR FREQUENT REPLACEMENT WITH CLEANING, DISINFECTION AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR FREQUENT REPLACEMENT, THE LENS MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM. FRESHLOOK SOFT CONTACT LENSES WITH UV-ABSORBING MONOMER HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.
-
-