Atlas FDA

UNISOL

FDA premarket approval P790011/S003 · decided 1981-09-01

Approval details

PMA number
P790011
Supplement
S003
Trade name
UNISOL
Generic name
Accessories, soft lens products
Applicant
Wesley Jessen Corp.
Date received
1981-04-28
Decision date
1981-09-01
Days to decision
126 days
Decision code
APPR
Product code
LPN
Advisory committee
Ophthalmic
Expedited review
No
Location
Chicago, IL

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
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS (K994335)Wesley Jessen Corp.2000-03-20
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C (K000439)Wesley Jessen Corp.2000-03-20
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI (K993935)Wesley Jessen Corp.1999-12-21
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES (K991000)Wesley Jessen Corp.1999-06-28
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS (K991550)Wesley Jessen Corp.1999-05-14
PRECISION UV (VASURFILCON A) (K982988)Wesley Jessen Corp.1999-01-06
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS (K982344)Wesley Jessen Corp.1998-12-22
D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES (K965052)Wesley Jessen Corp.1997-05-14