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RX-56 Semi-Rigid Gas Permeable Contact Lens

by Rynco Scientific Corp.

PMA N18114

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 N18114

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 NumberN18114 Date24 Sep 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  • Withdrawn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

Trade Name
Rx-56 Porofocon a Contact Lens
Generic Name
Lens, contact (polymethylmethacrylate)
PMA Number
FDA Product Code
HPX
Device Class
U
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S007

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 RX-56 Semi-Rigid Gas Permeable Contact Lens is classified as a Lens, Contact (Polymethylmethacrylate) under the FDA nomenclature. This device is designed as a semi-rigid, gas-permeable corneal-type contact lens intended for correcting vision deficiencies by being applied directly to the human eye.

This lens is supplied as a single-use or reusable product, depending on clinical practice, and is regulated under FDA Premarket Approval (PMA) with approval number N18114. It falls under product code HPX and is manufactured by Rynco Scientific Corp. in Floral Park, NY. The device is intended for ophthalmic use and adheres to regulatory standards for contact lenses.