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Boston Lens Clear

by Polymer Technology Corp.

PMA P820065

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 P820065↗

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 NumberP820065 Date28 Feb 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  • Withdrawn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
Boston Lens(R) Lens - Clear
Generic Name
Lens, contact (polymethylmethacrylate)
PMA Number
FDA Product Code
HPX
Device Class
U
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S007

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 Boston Lens Clear is a Lens, Contact (Polymethylmethacrylate), a type of intraocular or corneal prosthetic designed to replace or augment natural ocular optics. Manufactured from polymethylmethacrylate (PMMA), this device is intended for surgical implantation or fitting to restore vision in patients with corneal opacities, aphakia, or other conditions requiring optical correction.

Supplied as a sterile, single-use device, the Boston Lens Clear is regulated under FDA Premarket Approval (PMA) with PMA number P820065 and product code HPX. It is classified as FDA Unclassified (U) and is distributed by Polymer Technology Corp. from their facility at 100 Research Dr., Wilmington, MA 01887. Multiple registration numbers and FEI numbers (e.g., 1281950, 3002807465) further identify its regulatory compliance.

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