Atlas FDA

MIRASOL(TM)

FDA premarket approval P810008/S002 · decided 1982-11-22

Approval details

PMA number
P810008
Supplement
S002
Trade name
MIRASOL(TM)
Generic name
Accessories, soft lens products
Applicant
Wesley Jessen Corp.
Date received
1982-09-29
Decision date
1982-11-22
Days to decision
54 days
Decision code
APPR
Product code
LPN
Advisory committee
Ophthalmic
Expedited review
No
Location
Chicago, 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