510(k) clearances

Miru 1day UpSide (midafilcon A)

Menicon Co, Ltd. · Ophthalmic

K262495Substantially EquivalentTraditionalLPL
Open FDA's page for this record
Third party flag
N
City
Nagoya
Advisory committee description
Ophthalmic
Address 1
21-19, Aoi 3, Naka-Ku
Statement or summary
Summary
Product code
LPL
Zip code
460-0006
Applicant
Menicon Co, Ltd.
Decision date
2026-09-17
Decision code
SESE
Country code
JP
Device name
Miru 1day UpSide (midafilcon A)
Advisory committee
OP
Contact
Kana Nagasaki
K number
K262495
Date received
2026-07-20
Review advisory committee
OP
Postal code
460-0006
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
3014054090, 3015430860, 3008586477, 1052446, 3021632375, 3039590526, 3012138439, 3015146121, 3018616050, 3009108089, 3002807570, 3013170070, 3012862899, 3003515967, 1123818, 3012167421, 3041165456, 1067084, 3005395964, 9610790, 9710495, 3024762292, 3004529384, 3002732585, 3048347632, 2640128, 3008325767, 3035373204, 3043022738, 9680540, 1313525, 3005994941, 3022375855, 3007064560, 3025414414, 3012590738, 3003981983, 3045742980, 3010460316, 3015369246 +92 more
FEI number
3014054090, 3002806704, 3015430860, 3001064204, 3008586477, 3021632375, 3039590526, 3012138439, 3015146121, 3018616050, 1317628, 3003083595, 3009108089, 3006466212, 3002807570, 3013170070, 3012862899, 3003515967, 3012167421, 3041165456, 3005395964, 3024762292, 3004529384, 3002732585, 3048347632, 3008325767, 3035373204, 3043022738, 3005994941, 3022375855, 3007064560, 3025414414, 3012590738, 3003981983, 3045742980, 3010460316, 3015369246, 3005939549, 1610287, 3003062331 +92 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.