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SoftSite (Hefilcon A) Contact Lens

by Unilens Corporation, USA

PMA N17793

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 N17793

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 NumberN17793 Date30 Oct 1980ApprovedStatusActive

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  • Withdrawn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

Trade Name
Soft Site (Hefilcon a) Contact Lens
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
S003

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 SoftSite (Hefilcon A) Contact Lens is a soft contact lens designed for daily wear, classified under the generic name of Lenses, Soft Contact, Daily Wear. These lenses are intended to correct refractive errors and provide clear vision for patients requiring daily-use contact solutions.

This device is supplied as a single-use or disposable lens, intended for ophthalmic use only. It has received FDA Premarket Approval (PMA) under the product code LPL and regulation number 886.5925. The lenses are manufactured by Unilens Corporation and are regulated under the advisory committee for ophthalmic devices. No specific sterility or MRI safety information is provided in the data.

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Questions

AI-generated answers, 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.

  • Are these contact lenses designed for extended wear, or are they strictly for daily use only?

    The SoftSite (Hefilcon A) Contact Lens is explicitly designed for daily wear only, as stated in its generic name and description. It is not intended for extended or continuous wear beyond a single day.

  • How are these lenses supplied, and are they meant for single-use or reusable?

    The SoftSite (Hefilcon A) Contact Lens is supplied as a single-use or disposable lens, meaning each lens is intended for one-time use only. This aligns with its classification as a daily-wear contact lens.

  • What regulatory pathway was followed for FDA approval of this contact lens?

    The SoftSite (Hefilcon A) Contact Lens received FDA Premarket Approval (PMA) under product code LPL and regulation number 886.5925. The approval was granted through the Ophthalmic Devices advisory committee (OP) and was filed by Unilens Corporation in 1985.

  • Are there multiple sizes or models available for this contact lens?

    While the provided data lists multiple FEI numbers (e.g., 3015533540, 3012546757), these are administrative identifiers rather than direct indicators of distinct sizes or models. Typically, contact lenses like this would come in various base curves and diameters, but specific measurements or model variations are not detailed in the data.