Atlas FDA

SATURN II(TM) (SYNERGICON A) CONTACT LENS

FDA premarket approval P840004/S003 · decided 1987-01-29

Approval details

PMA number
P840004
Supplement
S003
Supplement type
THIRTY DAY TRACK
Supplement reason
Other
Trade name
SATURN II(TM) (SYNERGICON A) CONTACT LENS
Generic name
Lens, contact (polymethylmethacrylate)
Applicant
Wesley Jessen Corp.
Date received
1986-11-25
Decision date
1987-01-29
Days to decision
65 days
Decision code
APPR
Product code
HPX
Advisory committee
Ophthalmic
Expedited review
No
Location
Des Plaines, IL

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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