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Weicon (Tefilcon) Hydrophilic Contact Lenses

by Ciba Vision Corporation

PMA P800011

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 P800011↗

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 1 supplement NumberP800011 Date2 Dec 1982ApprovedStatusActive

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  • Withdrawn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

Generic Name
Lenses, soft contact, daily wear
PMA Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S004

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.

These are soft contact lenses designed for daily wear, classified as hydrophilic and intended for corneal refractive correction. The lenses are manufactured from Tefilcon, a hydrophilic material, and are intended to provide clear vision while maintaining comfort for extended periods of use.

The lenses are supplied as single-use, non-sterile items and are regulated under FDA Premarket Approval (PMA). They are intended for ophthalmic use and are distributed with specific registration and product codes (LPL). No MRI safety or reusable specifications are indicated in the data.

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