Boston Conditioning Solution

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

Full name

Boston Lens(R) Conditioning Solution

Generic Name

Accessories, soft lens products

PMA Number

P820070 ↗

510(k) Number

K923438 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

PMA Supplement

S007

• 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® Conditioning Solution primarily used for in clinical practice?

  The Boston Lens® Conditioning Solution is designed specifically for conditioning and storing soft contact lenses. Its purpose is to maintain lens hygiene and integrity between uses, ensuring lenses remain clean and properly preserved for safe and effective wear.

• Is the Boston Lens® Conditioning Solution available in single-use or multi-use formats, and how should I determine which variant to use?

  The Boston Lens® Conditioning Solution is available in both sterile single-use and multi-use formulations, depending on the specific variant. The choice between single-use and multi-use depends on clinical preference, patient hygiene protocols, and whether the solution will be shared across multiple lenses or used exclusively for one lens at a time. Always follow manufacturer guidelines and best practices for lens care.

• What storage conditions are recommended for the Boston Lens® Conditioning Solution, and how should it be handled after opening?

  While the exact storage instructions are not detailed in the provided data, the solution is supplied as sterile, so it should be stored in a clean, dry place away from direct sunlight and extreme temperatures. For multi-use variants, proper hygiene practices—such as using a clean container and replacing the solution regularly—are critical to prevent contamination. Always refer to the product labeling for specific storage and handling instructions.

• How do I know which variant or formulation of the Boston Lens® Conditioning Solution is right for my practice?

  The Boston Lens® Conditioning Solution comes in multiple formulations, each associated with specific registration and product codes (e.g., LPN). These variants may differ in composition, intended use (single-use vs. multi-use), or other clinical considerations. To determine the correct variant, consult the product labeling, manufacturer documentation, or contact Polymer Technology Corp. directly for guidance tailored to your practice’s needs.

• What regulatory pathways does the Boston Lens® Conditioning Solution follow, and how does this affect its use in clinical settings?

  The Boston Lens® Conditioning Solution is regulated under both FDA 510(k) and PMA pathways, with the original submission filed in 1992 and subsequent supplements. This classification under FDA regulation number 886.5928 ensures it meets stringent standards for ophthalmic accessories. Clinically, this means the solution has undergone rigorous evaluation for safety and effectiveness, but it does not imply any specific clinical indication—only that it complies with FDA requirements for conditioning and storing soft contact lenses.