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Softact II (Polymacon) Contact Lenses

by Premier Contact Lens

PMA P830006

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 P830006↗

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 NumberP830006 Date9 May 1985ApprovedStatusActive

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  • Withdrawn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
Softact II (Polymacon)
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
S001

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 Softact II (Polymacon) Contact Lenses are classified as soft contact lenses designed for daily wear. These lenses are intended to correct refractive errors and improve visual acuity by resting directly on the cornea, providing clear and comfortable vision for extended periods. Manufactured from polymacon, a silicone hydrogel material, they offer a balance of oxygen permeability and moisture retention to support corneal health during use.

These lenses are supplied as single-use or disposable, depending on the specific prescription and patient needs, and are regulated under FDA Premarket Approval (PMA). They are classified as Class II devices under the FDA’s regulatory framework, adhering to strict manufacturing and performance standards. The lenses are intended for use in ophthalmic settings, including eye care clinics and optometry practices, and must be handled and stored according to manufacturer guidelines to maintain sterility and integrity. The product is authorized under PMA number P830006.

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