SOFT-55 DAILY WEAR CONTACT LENS

K961428 · Lombart Lenses, Ltd. · LPL · May 21, 1996 · Ophthalmic

Device Facts

• Record ID: K961428
• Device Name: SOFT-55 DAILY WEAR CONTACT LENS
• Applicant: Lombart Lenses, Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: May 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Indications for Use

The Soft-55 daily wear lenses have the same intended use as the predicate Softcon® DW lens; they are fit on the cornea to correct the vision acuity of the patient.

Device Story

Soft-55 Vifilcon A daily wear plastic contact lens; fit on cornea to correct patient vision acuity. Device functions as refractive corrective lens; physical properties, light transmission, and refractive index comparable to predicate. Used by eye care professionals for patient vision correction.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, physical property, and manufacturing process comparison to predicate.

Technological Characteristics

Vifilcon A plastic contact lens; daily wear design. Characteristics include light transmission and refractive index comparable to predicate.

Indications for Use

Indicated for patients requiring vision acuity correction via corneal lens fitting.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

Predicate Devices

• Softcon® Daily Wear lens

Submission Summary (Full Text)

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Lombart Lenses Ltd.
1215 Boissevain Ave.
Norfolk, VA 23507

For Soft-55 Vifilcon A Daily Wear Plastic Contact Lens:

## Summary Of Safety And Effectiveness

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. Because the design is equivalent and the lens properties are equivalent and the manufacturing processes are equivalent, no new issues of safety or effectiveness are introduced by the Soft-55 lens. The Soft-55 daily wear lenses have the same intended use as the predicate Softcon® DW lens; they are fit on the cornea to correct the vision acuity of the patient. The lenses have identical indications, warnings, contra indications and produce the same effect on the eye. The Soft-55 lens is as safe and effective as the predicate device Softcon® Daily Wear lens.

K 961428

MAY 21 1996