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Combiflex

by Alcon Laboratories, Inc.

PMA P800001

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 P800001↗

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 NumberP800001 Date26 Apr 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  • Withdrawn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

Generic name
Accessories, soft lens products
FDA applicant
Alcon Laboratories
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

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 Combiflex is a soft lens accessory designed for ophthalmic use, specifically categorized under Accessories, Soft Lens Products. It is intended to assist in the handling, insertion, or removal of soft contact lenses, ensuring precision and ease of application.

This device is supplied as a reusable accessory, with no indication of sterility requirements in the provided data. It is regulated under the FDA’s Premarket Approval (PMA) pathway, with the product code LPN and PMA number P800001. No specific MRI safety or size variations are noted in the specifications.

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon 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 primary purpose of the Combiflex device in ophthalmic practice?

    The Combiflex is designed as a soft lens accessory to assist clinicians with the precise handling, insertion, or removal of soft contact lenses. Its purpose is to enhance ease and accuracy during these procedures, ensuring a smoother experience for both the practitioner and patient.

  • Is the Combiflex intended for single-use or reusable applications?

    The Combiflex is explicitly supplied as a reusable accessory. There is no indication in the provided data that it requires sterility for each use, though standard clinical disinfection practices should be followed to maintain hygiene.

  • How was the Combiflex regulated by the FDA, and what does that mean for its use?

    The Combiflex was approved through the FDA’s Premarket Approval (PMA) pathway, which is a rigorous review process for higher-risk medical devices. This means the device has undergone thorough evaluation for safety and effectiveness before being authorized for distribution and use in clinical settings.

  • Are there different sizes or models of the Combiflex available?

    The provided data does not specify any variations in size or model for the Combiflex. It is categorized under soft lens accessories without mention of customizable or interchangeable components, so it appears to be a standardized tool for general ophthalmic use.

  • What type of clinical setting or specialty is the Combiflex intended for?

    The Combiflex is categorized under ophthalmic accessories, specifically for soft lens products, and is associated with the medical specialty of ophthalmology. It is designed for use in eye care settings where soft contact lenses are handled, inserted, or removed.