Atlas FDA

KARATS MULTIPURPOSE SOLUTION

FDA 510(k) clearance K031753 · decided 2004-10-28

Clearance details

K-number
K031753
Device name
KARATS MULTIPURPOSE SOLUTION
Applicant
Ciba Vision Corporation
Decision
Substantially Equivalent
Date received
2003-06-05
Decision date
2004-10-28
Days to decision
511 days
Clearance type
Traditional
Product code
LPN
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Duluth, GA, 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
HYDROCURVE 3 TORIC (BUFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS (N17752/S038)Ciba Vision Corporation2001-08-16
SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A) (N17752/S037)Ciba Vision Corporation2000-09-18
CSI(CROFILCON A)EXTENDED WEAR SOFT (N17987/S028)Ciba Vision Corporation2000-09-18
CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A) (P850057/S006)Ciba Vision Corporation2000-09-18
GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES (P890012/S004)Ciba Vision Corporation2000-09-12
GENTLETOUCH (NETRAFILCON A)EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS (P890012/S005)Ciba Vision Corporation2000-05-02
CSI (CROFILCON A) EXTENDED WEAR SOFT (N17987/S027)Ciba Vision Corporation1999-11-18
CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS (N17987/S026)Ciba Vision Corporation1999-08-30