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Accusept Disinfecting Unit

by Strieter Laboratories, Inc.

PMA N17734

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 N17734

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 NumberN17734 Date17 Mar 1986ApprovedStatusActive

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  • Withdrawn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

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
S005

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 Accuscept Disinfecting Unit is a device designed for the disinfection of soft contact lenses intended for daily wear. Classified under the nomenclature for lenses, soft contact, daily wear, it is specifically engineered to process and sanitize these ophthalmic devices to ensure safety and hygiene before use.

This unit is supplied as a reusable medical device and is intended for use in ophthalmic settings, such as eye care clinics or optometry offices. It operates through a regulated disinfection process, adhering to FDA-authorized protocols under PMA number N17734. The device is not single-use and requires proper maintenance, storage, and periodic cleaning to comply with regulatory standards for reuse. No specific MRI safety information is provided, and its operation is governed by FDA regulations under classification 886.5925.

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 types of soft contact lenses is the Accuscept Disinfecting Unit designed to disinfect, and where is it typically used?

    The Accuscept Disinfecting Unit is specifically engineered for disinfecting soft contact lenses intended for daily wear. It is designed for use in ophthalmic settings such as eye care clinics or optometry offices, where maintaining lens hygiene is critical before patient use.

  • Is the Accuscept Disinfecting Unit a single-use device, or is it meant to be reused? What maintenance is required?

    The Accuscept Disinfecting Unit is not single-use—it is classified as a reusable medical device. To ensure proper function and compliance with regulatory standards, it requires periodic cleaning and maintenance as outlined in the manufacturer’s instructions. Reuse is governed by FDA protocols under its PMA authorization.

  • How is the regulatory approval process for this device structured, and what does the PMA number indicate?

    The Accuscept Disinfecting Unit holds an FDA Premarket Approval (PMA) under number N17734, meaning it underwent a rigorous review by the FDA’s Ophthalmic Advisory Committee (OP) before approval. The PMA process ensures the device meets safety and effectiveness standards for disinfecting soft contact lenses in clinical settings. The approval was finalized in 1986 after submission in 1985.

  • Are there any specific storage or handling instructions for the Accuscept Disinfecting Unit to maintain its functionality?

    While the provided data does not detail exact storage instructions, as a reusable medical device, the Accuscept Disinfecting Unit must be stored in a clean, dry environment and handled according to the manufacturer’s guidelines to prevent contamination. Proper maintenance, including cleaning, is essential to comply with FDA regulations and ensure reliable disinfection performance.