Atlas FDA

ALCON MULTI-PURPOSE DISINFECTING SOLUTION

FDA 510(k) clearance K050729 · decided 2005-09-14

Clearance details

K-number
K050729
Device name
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
Applicant
Alcon Research, Ltd.
Decision
Substantially Equivalent
Date received
2005-03-21
Decision date
2005-09-14
Days to decision
177 days
Clearance type
Traditional
Product code
LPN
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Fort Worth, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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PMA approvals by this applicant

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PROVISC™ Ophthalmic Viscosurgical Device (P890047/S069)Alcon Research, Ltd.2025-10-03
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S116)Alcon Research, Ltd.2025-09-18
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s (P040020/S115)Alcon Research, Ltd.2025-08-25
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S068)Alcon Research, Ltd.2025-07-25
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S111)Alcon Research, Ltd.2025-06-18
PROVSIC Ophthalmic Viscosurgical Device (P890047/S067)Alcon Research, Ltd.2025-02-26
AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL) (P040020/S113)Alcon Research, Ltd.2025-02-14