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SOF-FORM 55 (Methafilcon A) Soft Contact Lens

by Unilens Corp., USA

PMA P890040

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P890040↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP890040 Date28 Sep 1989ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Sof-Form 55 (Methafilcon a) Soft (Hydrophilic Lens
Generic Name
Lenses, soft contact, extended wear
PMA Number
FDA Product Code
LPM
Device Class
Class III
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SOF-FORM 55 (Methafilcon A) Soft Contact Lens is a soft contact lens designed for extended wear. Classified under the nomenclature ‘Lenses, soft contact, extended wear,’ it is a hydrophilic lens intended for corneal or scleral placement to correct refractive errors.

These lenses are supplied sterile and intended for single-use. They are regulated under FDA PMA (Premarket Approval) as a Class III device, adhering to regulation number 886.5925. Multiple registration numbers and FEI numbers identify specific variants, with no indication of MRI safety or reusable components. Storage and handling must comply with sterile contact lens protocols.

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