Atlas FDA

AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION

FDA 510(k) clearance K093254 · decided 2010-09-15

Clearance details

K-number
K093254
Device name
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
Applicant
Abbott Medical Optics, Inc.
Decision
Substantially Equivalent
Date received
2009-10-16
Decision date
2010-09-15
Days to decision
334 days
Clearance type
Traditional
Product code
LPN
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Santa Ana, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HEALON D SODIUM HYALURONATE SOLUTION (P880031/S016)Abbott Medical Optics, Inc.2009-02-18
VITRAX/HEALON D SODIUM HYALURONATE SOLUTION OPHTHALMIC VISCOSURGICAL DEVICES (P880031/S015)Abbott Medical Optics, Inc.2008-09-19
HEALON D (P880031/S014)Abbott Medical Optics, Inc.2008-08-22
CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS (P960034/S002)Abbott Medical Optics, Inc.2007-05-08
CEEON HSM UV LIGHT ABSORBING PMMA ANTERIOR CHAMBER IOLS (P880070/S012)Abbott Medical Optics, Inc.2007-05-08
CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS) (P880070/S011)Abbott Medical Optics, Inc.2005-02-04
MODEL HSM65 UV ABSORBING PMMA ANTERIOR CHAMBER LENS (P880070/S010)Abbott Medical Optics, Inc.2004-03-17
POLYMETHYLMETHACRYLATE(PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (P960034/S001)Abbott Medical Optics, Inc.2000-02-07