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Paraperm O2 Clear & Blue Lens

by Salvatori Ophthalmics Mfg. Corp.

PMA P820062

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 P820062↗

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 NumberP820062 Date16 Mar 1984ApprovedStatusActive

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  • Withdrawn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
Lens, contact (other material) - daily
PMA Number
FDA Product Code
HQD
Device Class
Class II
Regulation
21 CFR Part 886.5916
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 Paraperm O2 Clear & Blue Lens is a daily-use contact lens made from an unspecified alternative material, designed for ophthalmic applications. It is classified as a Class II medical device under FDA regulations, intended for temporary corneal reshaping and vision correction.

This lens is supplied as a single-use, non-sterile product and is regulated under FDA Premarket Approval (PMA) with PMA number P820062. It is intended for use in clinical settings where corneal refractive therapy or orthokeratology may be administered, adhering to the specifications outlined in regulation number 886.5916. The lens is available in various sizes and configurations as referenced in the registration numbers provided.

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