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HYDRO MARC LENSES (HYDROPHILIC)

FDA premarket approval N18033/S005 · decided 1982-09-09

Approval details

PMA number
N18033
Supplement
S005
Trade name
HYDRO MARC LENSES (HYDROPHILIC)
Generic name
Lenses, soft contact, daily wear
Applicant
Vistakon, Johnson & Johnson Vision Products, Inc.
Date received
1982-07-07
Decision date
1982-09-09
Days to decision
64 days
Decision code
APPR
Product code
LPL
Advisory committee
Ophthalmic
Expedited review
No
Location
Jacksonville, FL

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510(k) clearances by this applicant

RecordFirmDate
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (K994324)Vistakon, Johnson & Johnson Vision Products, Inc.2000-02-23
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (K994318)Vistakon, Johnson & Johnson Vision Products, Inc.2000-02-23
VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR (K991163)Vistakon, Johnson & Johnson Vision Products, Inc.1999-06-08
ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR (K991134)Vistakon, Johnson & Johnson Vision Products, Inc.1999-05-06
VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER (K983912)Vistakon, Johnson & Johnson Vision Products, Inc.1999-01-26
VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT (K964612)Vistakon, Johnson & Johnson Vision Products, Inc.1997-01-30
ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER (K962804)Vistakon, Johnson & Johnson Vision Products, Inc.1996-10-01
VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS (K953804)Vistakon, Johnson & Johnson Vision Products, Inc.1995-09-26