510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Visionary Optics, LLC

Front Royal, VA, US

Visionary Optics, LLC appears in FDA device records in Front Royal, VA. FDA records list 3 510(k) clearances between and , no PMA records and 2 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
3
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 3 510(k) clearances for Visionary Optics, LLC between 2017 and 2024. The busiest year on record is 2017, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Visionary Optics, LLC, by decision year
YearClearances
20171
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)HQDSubstantially Equivalent
K223394Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)HQDSubstantially Equivalent
K171950Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)HQDSubstantially Equivalent

Registered establishments

FDA registered establishments for Visionary Optics, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10001232211000123221Visionary Optics, LLC1325 Progress Drive, Front Royal, VA 22630 US2026
30433655833043365583Visionary Optics, LLC45472 Holiday Dr STE 5, Sterling, VA 20166 US2026

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