510(k) clearances

Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens

Bausch + Lomb, Inc. · Ophthalmic

K262941Substantially EquivalentTraditionalLPL
Open FDA's page for this record
Third party flag
N
City
Rochester
Advisory committee description
Ophthalmic
Address 1
1400 N Goodman St.
Statement or summary
Summary
Product code
LPL
Zip code
14609
Applicant
Bausch + Lomb, Inc.
Decision date
2026-10-16
Decision code
SESE
Country code
US
Device name
Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
Advisory committee
OP
Contact
Kaelan Sarin
K number
K262941
State
NY
Date received
2026-08-21
Review advisory committee
OP
Postal code
14609
Decision description
Substantially Equivalent
Clearance type
Traditional
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.