Boston Lens Cleaner

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Boston Lens(R) Cleaner

Generic Name

Accessories, soft lens products

PMA Number

P820069 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S003

• Rigid Gas Permeable Contact Lens

  Class II

  FDA 510(k) K000795 Active Cleared 26 May 2000

• Empty Solution Transfer Container 1000

  Class II

  FDA 510(k) K843523 Active Cleared 16 Oct 1984

• Boston Liquid Enzymatic Cleaner

  Class II

  FDA 510(k) K973217 Active Cleared 24 Nov 1997

• Rigid Gas Permeable Contact Lens Solution

  Class II

  FDA 510(k) K011945 Active Cleared 12 Sep 2001

• Embedding Ring

  Class I

  FDA 510(k) K831922 Active Cleared 29 Jul 1983

• Boston Es Multivision (Enflufocon a) Contact Lens

  Class II

  FDA 510(k) K970698 Active Cleared 6 May 1997

See all devices from Polymer Technology Corp. →

• What is the Boston Lens Cleaner specifically designed to do for soft contact lenses?

  The Boston Lens Cleaner is a liquid solution intended to remove deposits, proteins, and other contaminants from the surface of soft contact lenses. This helps maintain lens clarity and hygiene, ensuring safe and comfortable wear for patients by keeping the lenses clean and free of buildup.

• Is the Boston Lens Cleaner meant for single-use or repeated use, and how should it be stored?

  The Boston Lens Cleaner is intended for single-use per manufacturer guidelines. Since it is non-sterile, it must be stored in a cool, dry place away from direct sunlight to preserve its effectiveness and prevent degradation.

• What regulatory pathway does the Boston Lens Cleaner follow, and what class does it belong to?

  The Boston Lens Cleaner follows the FDA Premarket Approval (PMA) pathway, with an approval number of P820069. It is classified under device class II, specifically under the product code LPN (Lens Products, Non-Prescription).

• How does the Boston Lens Cleaner differ from other cleaning solutions for soft contact lenses?

  The Boston Lens Cleaner is specifically formulated as a concentrated solution designed to remove proteins and deposits from soft contact lenses, ensuring they remain clear and hygienic. Unlike some other solutions, it is explicitly regulated under FDA PMA and is non-sterile, requiring careful storage to maintain its intended performance.