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Dynasol 4

by Steridyne Laboratories, Inc.

PMA P880080

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 P880080↗

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 NumberP880080 Date20 Jun 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  • Withdrawn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
S004 (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 Dynasol 4 is a soft lens accessory designed for ophthalmic use, classified under the nomenclature for Accessories, Soft Lens Products. It is intended for cleaning, storing, or handling soft contact lenses to maintain hygiene and integrity.

Supplied as a reusable device, the Dynasol 4 is intended for use in clinical and home settings. Authorized under FDA PMA (P880080), it adheres to regulatory standards for ophthalmic accessories, with labeling changes tracked through supplement S004. No specific sterility or MRI safety information is provided in the data.

Other devices from Steridyne Laboratories, Inc.

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.

  • What is the Dynasol 4 used for?

    The Dynasol 4 is a soft lens accessory designed for cleaning, storing, or handling soft contact lenses to maintain hygiene and integrity in both clinical and home settings.

  • Is the Dynasol 4 a single-use or reusable device?

    The Dynasol 4 is supplied as a reusable device, meaning it can be used multiple times for its intended purpose of soft lens care.

  • What regulatory authorization does the Dynasol 4 have?

    The Dynasol 4 is authorized under FDA PMA (P880080) and is classified as an accessory for soft lens products, adhering to regulatory standards for ophthalmic accessories.

  • Are there different sizes or models of the Dynasol 4 available?

    The device data does not specify different sizes or models for the Dynasol 4, indicating it may be available in a standard configuration.

  • What information is provided about the sterility of the Dynasol 4?

    The device data does not include specific information regarding the sterility status of the Dynasol 4, so details about its sterile condition are not available.