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Silcon (Silafilcon A) Contact Lens Daily Wear

by Dow Corning Corp. Healthcare Industries Materials

PMA P800054

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 P800054↗

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 NumberP800054 Date31 Oct 1984ApprovedStatusActive

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  • Withdrawn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
Silcon(R) (Silafilcon a) Contact Lens Daily Wear
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
S008

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.

This device is a Lenses, Soft Contact, Daily Wear, as classified by the FDA. It consists of silicone hydrogel contact lenses designed for daily wear, providing clear vision while maintaining ocular comfort for extended periods. The material, Silafilcon A, balances oxygen permeability with moisture retention to support corneal health during prolonged use.

The lenses are intended for single-use, requiring replacement after each wearing session to ensure hygiene and safety. They are supplied sterile in individual blister packs and must be handled with clean hands or sterile applicators. Authorized under FDA_PMA (PMA Number: P800054), these lenses adhere to regulatory standards for ophthalmic devices, ensuring compliance with 886.5925 for soft contact lenses. No MRI safety or reusable specifications are noted in the data.

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