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YDRON Hydrophilic Contact Lenses (Polymacon)

by Les Laboratories Blonchard

PMA P910029

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P910029↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP910029 Date23 Nov 1993ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
\ydron(R) (Polymacon) Hydrophilic Contact Lenses
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 (Normal 180 Day Track)

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.

This device is a Lens, Soft Contact, Daily Wear, designed for ophthalmic use. It consists of hydrophilic polymacon material, intended for correction or modification of refractive errors, providing clear vision while maintaining comfort for daily wear.

The lenses are supplied as single-use, non-sterile items, intended for professional fitting and dispensing by eye care practitioners. They are regulated under FDA Premarket Approval (PMA P910029) and fall under device class II (product code LPL). Storage and handling must comply with ophthalmic best practices to ensure safety and efficacy.

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.

  • Are these contact lenses intended for overnight wear or only daily use?

    The YDRON® (POLYMACON) HYDROPHILIC CONTACT LENSES are explicitly designed for daily wear only, as stated in the device description. They are not approved or intended for extended or overnight use, which requires specialized materials and regulatory pathways not applicable here.

  • How should these lenses be stored before use, and are they sterile?

    The lenses are non-sterile and supplied for single-use only, meaning they must be handled and stored according to ophthalmic best practices to ensure safety. Since they are not sterile, they require professional fitting and dispensing by eye care practitioners, who will provide appropriate storage and handling instructions (e.g., sealed packaging until use).

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

    The YDRON® (POLYMACON) HYDROPHILIC CONTACT LENSES underwent FDA Premarket Approval (PMA P910029), which is the highest regulatory standard for medical devices in the U.S. This device is classified under FDA Class II (product code LPL), indicating it poses moderate risk and requires special controls to ensure safety and effectiveness.

  • Are these lenses reusable, or are they intended for one-time use?

    These lenses are intended for single-use only, as explicitly stated in the device description. They are not designed for reuse, which aligns with daily-wear contact lens standards to minimize infection risks and ensure patient safety.