Atlas FDA

AL-47 SOFT CONTACT LENS

FDA premarket approval P820078 · decided 1984-01-30

Approval details

PMA number
P820078
Trade name
AL-47 SOFT CONTACT LENS
Generic name
Lenses, soft contact, daily wear
Applicant
Alden Optical Labs., Inc.
Date received
1982-10-27
Decision date
1984-01-30
Days to decision
460 days
Decision code
APRL
Product code
LPL
Advisory committee
Ophthalmic
Expedited review
No
Location
Alden, NY

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510(k) clearances by this applicant

RecordFirmDate
IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) (K133079)Alden Optical Labs., Inc.2013-12-17
NOVAKONE SPHERICAL AND TORIC LENSES (K102557)Alden Optical Labs., Inc.2011-04-26
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES (K091327)Alden Optical Labs., Inc.2010-06-25
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL (K052703)Alden Optical Labs., Inc.2005-11-10
ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES (K042242)Alden Optical Labs., Inc.2004-09-15
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) (K983278)Alden Optical Labs., Inc.1998-11-25
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) (K983053)Alden Optical Labs., Inc.1998-10-21
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) (K981252)Alden Optical Labs., Inc.1998-06-23