Boston Cleaner II

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

Full name

The Boston Tm Cleaner II

Generic Name

Accessories, soft lens products

PMA Number

P890054 ↗

510(k) Number

K923437 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

PMA Supplement

S001 (Normal 180 Day Track)

• 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

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• Is the Boston Cleaner II designed for single-use or can it be reused over multiple cleaning cycles?

  The Boston Cleaner II is explicitly described as a **reusable** accessory for cleaning and maintaining soft contact lenses. Since it is intended for repeated use in ophthalmic settings, proper cleaning and maintenance between uses are essential to ensure hygiene and functionality.

• How should the Boston Cleaner II be stored to maintain its functionality and sterility?

  The device requires **proper storage** to preserve its functionality and sterility, though specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data. Since it is reusable, it should be cleaned and disinfected between uses, and stored in a clean, dry environment to prevent contamination.

• Is the Boston Cleaner II compatible with MRI procedures, or are there any safety concerns?

  The Boston Cleaner II is **not MRI-safe**, meaning it should not be used or stored in an MRI environment. This is explicitly stated in the device description, so clinicians should ensure it is removed from contact lenses before MRI procedures.

• What regulatory pathways does the Boston Cleaner II follow, and how was its equivalence determined?

  The Boston Cleaner II was cleared through the **FDA 510K and PMA pathways**, with a **traditional clearance type** and a **substantially equivalent (SESE)** determination by the Ophthalmic (OP) Advisory Committee. Its classification falls under **21 CFR 886.5928**, confirming its regulatory status as an accessory for soft lens products.

• What types of contact lenses is the Boston Cleaner II intended to clean, and are there any specific lens materials it works with?

  The Boston Cleaner II is designed as an **accessory for soft lens products**, meaning it is intended for use with **soft contact lenses**—not rigid gas-permeable or hard lenses. While the device itself does not specify lens material compatibility, its role is to ensure proper hygiene for soft lenses in ophthalmic care settings.