510(k) clearances

Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker

CooperVision, Inc. · Ophthalmic

K234127Substantially EquivalentSpecialLPL
Open FDA's page for this record
Third party flag
N
City
San Ramon
Advisory committee description
Ophthalmic
Address 1
6101 Bollinger Canyon Rd.
Address 2
Suite 500
Statement or summary
Summary
Product code
LPL
Zip code
94583
Applicant
CooperVision, Inc.
Decision date
2024-01-25
Decision code
SESE
Country code
US
Device name
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
Advisory committee
OP
Contact
Sahana Rajashekar
K number
K234127
State
CA
Date received
2023-12-28
Review advisory committee
OP
Postal code
94583
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Lenses, Soft Contact, Daily Wear
Medical specialty description
Ophthalmic
Regulation number
886.5925
Device class
2
Registration number
3009633067, 3035385765, 3041165456, 3039456814, 3036689755, 3044853379, 3013170070, 3009674807, 3017889743, 1053053, 3009518015, 3012123291, 3013785060, 3012862899, 3043022738, 1066578, 3004585750, 1610287, 3021632375, 1119279, 3004021238, 3010392968, 3008034930, 3012918760, 1313525, 1627258, 3012138439, 2919245, 3003228982, 3006946962, 3018616050, 2640128, 3006297986, 3003657720, 2024119, 3006186389, 9680540, 3011989923, 9614761, 3013124682 +93 more
FEI number
3009633067, 3035385765, 3002807717, 3041165456, 3039456814, 3036689755, 3044853379, 3005939549, 3002806704, 3013170070, 3009674807, 3001064204, 3017889743, 1053053, 3009518015, 3012123291, 3013785060, 3012862899, 3043022738, 3003040707, 3004585750, 1610287, 3021632375, 1119279, 3004021238, 3010392968, 1000140384, 3008034930, 3012918760, 1627258, 3012138439, 2919245, 3003228982, 3006946962, 3018616050, 3006297986, 3003657720, 3002806417, 2024119, 3003076831 +93 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.