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510(k) Data Aggregation
K Number
K971647Device Name
LL BI-FOCAL, DAILY WEAR CONTACT LENS
Manufacturer
LOMBART LENSES, LTD.
Date Cleared
1997-07-15
(71 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
LOMBART LENSES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LL Bi-Focal Soft (hydrophilic) Contact Lenses are indicated for daily wear by presbyopic patients with non-diseased eyes who are not aphakic and who have no more than 2.00 diopters of astigmatism and require powers from -6.00 to +6.00 and add powers of +1.50, +2.50 or +3.00.
Device Description
LL Bi-Focal , Soft (hydrophilic) Contact lens for Daily Wear
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K Number
K961428Device Name
SOFT-55 DAILY WEAR CONTACT LENS
Manufacturer
LOMBART LENSES, LTD.
Date Cleared
1996-05-21
(36 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
LOMBART LENSES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Soft-55 daily wear lenses have the same intended use as the predicate Softcon® DW lens; they are fit on the comea to correct the vision acuity of the patient. The lenses have identical indications, warnings, contra indications and produce the same effect on the eye.
Device Description
The Soft-55 daily wear contact lens design is substantially equivalent to the designs of the predicate lens currently in commercial distribution (Softcon® Daily Wear lens). The Soft-55 lens also has light transmission, refractive index and physical characteristics comparable to the predicate Softcon® Daily Wear lens.
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