510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Luxottica Group S.p.A.

Milan Milano, IT

LUXOTTICA GROUP S.P.A appears in FDA device records in Milan Milano, IT. FDA records list one 510(k) clearance, no PMA records and 3 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
0
Registered establishments
3

510(k) clearance history

FDA records hold 1 510(k) clearance for Luxottica Group S.p.A. in 2025.

Clearances by year, as a table
510(k) clearance decisions for Luxottica Group S.p.A., by decision year
YearClearances
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243150Nuance Audio Hearing Aid SoftwareSCRSubstantially Equivalent

Registered establishments

FDA registered establishments for Luxottica Group S.p.A., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30110165063011016506LUXOTTICA GROUP S.P.APiazzale Cadorna, 3, Milan Milano 20123 IT2026
96148273001654059LUXOTTICA Group SPAVIA VALOCOZZENA, AGORDO Belluno 32021 IT2026
96149003009586234Luxottica Group S.P.A.Via Vila 2/A, Sedico Belluno 32036 IT2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain