Atlas FDA

COMPLETE BRAND MULTI-PURPOSE SOLUTION

FDA 510(k) clearance K030092 · decided 2003-04-04

Clearance details

K-number
K030092
Device name
COMPLETE BRAND MULTI-PURPOSE SOLUTION
Applicant
Advanced Medical Optics, Inc.
Decision
Substantially Equivalent
Date received
2003-01-10
Decision date
2003-04-04
Days to decision
84 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
CEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) (P810055/S072)Advanced Medical Optics, Inc.2008-07-02
CEEON PMMA UV-LIGHT ABSORBING POSTERIOR CHAMBER (IOLS) (P810055/S071)Advanced Medical Optics, Inc.2005-02-04
CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (P940007/S006)Advanced Medical Optics, Inc.2001-04-02
MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS (P810055/S069)Advanced Medical Optics, Inc.1999-12-03
CEEON MODEL 912 FOLDABLE INTRAOCULAR LENS (P940007/S005)Advanced Medical Optics, Inc.1999-07-30
PERMAFLEX NATURALS (P790020/S059)Advanced Medical Optics, Inc.1998-10-27
SILICONE POSTERIOR CHAMBER INTRACULAR LENSES IOL MODEL 127(920) (P940007/S004)Advanced Medical Optics, Inc.1998-09-29
MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS (P810055/S070)Advanced Medical Optics, Inc.1998-07-15