PMA P830071

Device: ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392
Applicant: Alcon Laboratories
PMA number: P830071
Supplement: S008
Product code: LPN
Decision date: 1997-05-15
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR (1) USE OF OPTI-SOAK(R) CONDITIONING SOLUTION AS AN ALTERNATE DILUENT FOR OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER, (2) TO EXPAND THE INDICATIONS FOR USE OF OPTI-FREE(R) SUPRACLENS(TM) TO ALLOW FOR USE WITH RIGID GAS PERMEABLE (RGP) CONTACT LENSES, AND (3) FOR USE OF OPTI-CLEAN(R) II DAILY CLEANER AS AN ALTERANTE DAILY CLEANER IN THE OPTI-SOAK(R) LENS CARE REGIMEN.

Current openFDA PMA Record#

Device: ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392
Applicant: Alcon Laboratories
PMA number: P830071
Supplement: S008
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1997-05-15
Decision code: APPR
Date received: 1996-12-18
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR (1) USE OF OPTI-SOAK(R) CONDITIONING SOLUTION AS AN ALTERNATE DILUENT FOR OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER, (2) TO EXPAND THE INDICATIONS FOR USE OF OPTI-FREE(R) SUPRACLENS(TM) TO ALLOW FOR USE WITH RIGID GAS PERMEABLE (RGP) CONTACT LENSES, AND (3) FOR USE OF OPTI-CLEAN(R) II DAILY CLEANER AS AN ALTERANTE DAILY CLEANER IN THE OPTI-SOAK(R) LENS CARE REGIMEN.