Atlas FDA

ACUVUE CONTACT LENS

FDA premarket approval N18033 · decided 1980-03-18

Approval details

PMA number
N18033
Trade name
ACUVUE CONTACT LENS
Generic name
Lenses, soft contact, extended wear
Applicant
Vistakon, Johnson & Johnson Vision Products, Inc.
Date received
1980-01-01
Decision date
1980-03-18
Days to decision
77 days
Decision code
APPR
Product code
LPM
Advisory committee
Ophthalmic
Expedited review
No
Location
Jacksonville, FL

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

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