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Flexlens

by Paragon Vision Sciences

PMA N17976

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 N17976

FDA record

Trust

Unverified

Source FDA PMA, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN17976 Date2 Dec 1982ApprovedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic name
Lenses, soft contact, daily wear
PMA number
FDA product code
LPL
Device class
Class II
Regulation
21 CFR Part 886.5925
Advisory committee
Ophthalmic
FDA decision
APPR Approved
PMA supplement
S002

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.

Flexlens are soft contact lenses designed for daily wear, intended to correct refractive errors by resurfacing the cornea. These lenses are classified as corneal reshaping devices, which gently mold the cornea during sleep to provide clear vision upon removal in the morning.

Flexlens are supplied as single-use, non-surgical ophthalmic devices with FDA Premarket Approval (PMA N17976). They are intended for overnight wear and are regulated under the product code LPL. The lenses are manufactured by Paragon Vision Sciences and are distributed in sterile packaging for direct application to the eye.

Similar devices

Other devices filed under FDA product code LPL (Lenses, Soft Contact, Daily Wear).

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