510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Vistakon, Johnson & Johnson Vision Products, Inc.

Jacksonville, FL, US

Vistakon, Johnson & Johnson Vision Products, Inc. appears in FDA device records in Jacksonville, FL. FDA records list 8 510(k) clearances between and , 108 PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
8
PMA records
108
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 8 510(k) clearances for Vistakon, Johnson & Johnson Vision Products, Inc. between 1995 and 2000. The busiest year on record is 1999, with 3. The most recent is 2000, with 2.

Clearances by year, as a table
510(k) clearance decisions for Vistakon, Johnson & Johnson Vision Products, Inc., by decision year
YearClearances
19951
19961
19971
19993
20002
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K994324ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKERLPLSubstantially Equivalent
K994318VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKERLPLSubstantially Equivalent
K991163VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEARLPLSubstantially Equivalent
K991134ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEARLPLSubstantially Equivalent
K983912VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKERLPLSubstantially Equivalent
K964612VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINTLPLSubstantially Equivalent
K962804ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKERLPLSubstantially Equivalent
K953804VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENSLPLSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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