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Mirasol Soft Lens Accessories

by Wesley Jessen Corp.

PMA P810008

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 P810008↗

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 NumberP810008 Date1 Jul 1983ApprovedStatusActive

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  • Withdrawn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
Mirasol(Tm)
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
S003

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 Mirasol Soft Lens Accessories are classified as ophthalmic devices designed to support the handling, storage, and maintenance of soft contact lenses. These accessories include components such as lens cases, cleaning solutions, and storage systems tailored for soft lens care, ensuring proper hygiene and lens integrity.

These accessories are supplied as non-sterile, reusable items intended for use in ophthalmic settings, including clinical and home environments. They are regulated under FDA Premarket Approval (PMA) with PMA number P810008 and fall under device class II. Compliance with FDA regulation number 886.5928 ensures adherence to safety and performance standards for ophthalmic accessories.

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