Search Results
Found 5 results
510(k) Data Aggregation
K Number
K021143Device Name
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
Manufacturer
Date Cleared
2002-08-08
(121 days)
Product Code
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
ALCON UNIVERSAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.
OPTI-FREE® EXPRESS® Multi-Purpose Disinfecting Solution can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
Device Description
OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, TETRONIC® 1304, with edetate disodium 0.05%, POLYQUAD® (polyquaternium-1) 0.001% and ALDOX™ (myristamidopropyl dimethylamine) 0.0005% as preservatives.
Ask a Question
Ask a specific question about this device
K Number
K002589Device Name
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
Manufacturer
Date Cleared
2000-10-23
(63 days)
Product Code
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
ALCON UNIVERSAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K001214Device Name
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
Manufacturer
Date Cleared
2000-07-10
(87 days)
Product Code
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
ALCON UNIVERSAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K001235Device Name
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
Manufacturer
Date Cleared
2000-07-03
(77 days)
Product Code
Regulation Number
886.5918Why did this record match?
Applicant Name (Manufacturer) :
ALCON UNIVERSAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K000385Device Name
OPTI-FREE EXPRESS LENS DROPS
Manufacturer
Date Cleared
2000-04-28
(81 days)
Product Code
Regulation Number
886.5918Why did this record match?
Applicant Name (Manufacturer) :
ALCON UNIVERSAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
Page 1 of 1