Atlas FDA

CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k) clearance K073060 · decided 2007-11-29

Clearance details

K-number
K073060
Device name
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Applicant
Innova Vision, Inc.
Decision
Substantially Equivalent
Date received
2007-10-30
Decision date
2007-11-29
Days to decision
30 days
Clearance type
Special
Product code
MVN
Device class
2
Regulation number
886.5925
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Flagstaff, AZ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens (K261812)HOYA Lamphun , Ltd.2026-07-07
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202448)Alcon Laboratories, Inc.2020-09-22
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202036)Alcon Laboratories, Inc.2020-08-21
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear (K150630)Yung Sheng Optical Co., Ltd.2015-06-15
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens (K143190)Yung Sheng Optical Co., Ltd.2015-01-16
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER (K130331)Sauflon Pharmaceuticals, Ltd.2013-07-26
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS (K112192)Bausch & Lomb, Inc.2011-10-25
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS (K080632)Clearlab SG Pte, Ltd.2008-10-15
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K080755)Bausch & Lomb, Inc.2008-06-10
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS (K061948)CooperVision, Inc.2006-11-22
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K061157)Bausch & Lomb2006-06-22
SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES (K052832)Sauflon Pharmaceuticals, Ltd.2006-05-15

Recalls involving this device

No recalls on record reference this clearance.