Atlas FDA

AQUIFY LENS COMFORT DROPS

FDA 510(k) clearance K013204 · decided 2002-04-03

Clearance details

K-number
K013204
Device name
AQUIFY LENS COMFORT DROPS
Applicant
Ciba Vision Corporation
Decision
Substantially Equivalent
Date received
2001-09-25
Decision date
2002-04-03
Days to decision
190 days
Clearance type
Traditional
Product code
MRC
Device class
2
Regulation number
886.5918
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

RecordFirmDate
AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Len recall (Z-0182-06)Ciba Vision Corporation2005-11-23

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