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Steridyne Soft (Hydrophilic) Lens Solution

by Steridyne Laboratories, Inc.

PMA P890067

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P890067↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP890067 Date18 Jan 1991ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Accessories, soft lens products
PMA Number
FDA Product Code
LPN
Device Class
Class II
Regulation
21 CFR Part 886.5928
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S001 (Normal 180 Day Track)

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 Steridyne Soft (Hydrophilic) Lens Solution is a sterile ophthalmic solution designed for cleaning, disinfecting, and storing soft contact lenses. Classified under the nomenclature for soft lens products, it is formulated to maintain lens hygiene and integrity while ensuring compatibility with hydrophilic materials.

This solution is supplied as a single-use or multi-use formulation, depending on the specific lot, and is intended for use in ophthalmic settings. It is regulated under FDA Premarket Approval (PMA) with PMA number P890067 and falls under regulation number 886.5928. Sterility is ensured through manufacturing processes, and the product is packaged for clinical use in eye care practices.

Other devices from Steridyne Laboratories, Inc.