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Softmate Sol.

by Advanced Medical Optics, Inc.

PMA N18073

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 N18073

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 NumberN18073 Date31 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  • Withdrawn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

Full name
Softmate
Trade Name
Softmate Sol.
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
S006

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 Softmate Sol. is a soft lens product accessory designed for ophthalmic use. It falls under the category of accessories for soft contact lenses, intended to facilitate handling, storage, or cleaning of these lenses in clinical or home settings.

This device is supplied as a single-use or reusable solution, depending on the specific formulation and intended use as indicated by the product codes. Authorized under FDA Premarket Approval (PMA), it is regulated under regulation number 886.5928 and falls under device class II. The product is distributed in various sizes and formulations, as referenced by the associated registration numbers.

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