Skip to content

Adapettes

by Alcon Laboratories, Inc.

PMA N17945

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 N17945

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 NumberN17945 Date20 Dec 1985ApprovedStatusActive

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  • Withdrawn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
Adapettes Lubrication & Rewetting Soln for Sensiti
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
S020

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 Adapettes are classified as Accessories, Soft Lens Products, designed to facilitate the handling, insertion, and removal of soft contact lenses. These devices are engineered to improve precision and comfort during lens manipulation, reducing potential irritation or damage to the lens material.

Supplied as single-use items, Adapettes are intended for use in ophthalmic settings and are regulated under FDA_PMA with approval number N17945. They are non-sterile and must be handled in accordance with sterile techniques when used in clinical procedures. The product adheres to device class 2 standards and is governed by regulation 886.5928

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 Adapettes in clinical ophthalmology settings?

    Adapettes are designed as accessories to assist with the precise handling, insertion, and removal of soft contact lenses. Their engineering aims to minimize potential irritation or damage to the lens material, thereby improving patient comfort and safety during lens manipulation.

  • Are Adapettes intended for single-use or repeated use in clinical procedures?

    Adapettes are explicitly supplied as single-use items. This design ensures hygiene and reduces the risk of cross-contamination, particularly important in sterile clinical environments where lens handling occurs.

  • What regulatory pathway was followed for the approval of Adapettes, and what class does this device fall under?

    Adapettes were approved through the FDA’s Premarket Approval (PMA) process under authorization code N17945. They are classified as a Class II medical device, governed by regulation number 886.5928, which reflects their role as accessories for soft lens products.

  • Since Adapettes are non-sterile, how should they be handled during clinical procedures?

    Because Adapettes are non-sterile, they must be used in accordance with sterile techniques when applied in clinical settings. This means the clinician should follow standard aseptic practices, such as using sterile gloves and maintaining a clean workspace, to prevent contamination during lens handling.

  • What types of soft contact lenses are Adapettes compatible with, and are there specific sizes or models available?

    While the data does not specify exact lens compatibility, Adapettes are designed as general-purpose accessories for soft contact lenses and are not limited to a particular brand or type. The product is supplied in multiple FEI numbers (e.g., 1610287, 3010607087), which may correspond to different sizes or variants, but no detailed sizing information is provided in the data.