Brite Stock Cleaning / Disinfecting Solution

• • Terminated Z-0987-05 FDA Unclassified (pre-2012) ·initiated 13 Jun 2005

  Component mix-up of caps/tips. Absence of red tip indicates improperly that the solution is safe for application to the eye.

Generic Name

Accessories, soft lens products

PMA Number

P870023 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S005 (Normal 180 Day Track)

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See all devices from Advanced Medical Optics, Inc. →

• What is the BRITE Stock Cleaning / Disinfecting Solution primarily used for in clinical settings?

  The BRITE Stock Cleaning / Disinfecting Solution is designed specifically for ophthalmic use to maintain and sterilize lens cases and stock solutions. Its purpose is to prevent microbial contamination and ensure proper hygiene in soft contact lens care routines, helping to reduce the risk of infections associated with lens storage and maintenance.

• Is this solution intended for single-use only, or can it be reused in a controlled environment?

  The BRITE Stock Cleaning / Disinfecting Solution is supplied as a liquid for manual application and is explicitly intended for both single-use and repeated use in a controlled environment, such as a clinical or home setting where proper hygiene protocols are followed. This flexibility allows for flexibility in usage depending on clinical or patient needs.

• How should the BRITE Stock Cleaning / Disinfecting Solution be stored, and what determines its shelf life?

  Storage conditions and shelf life for the BRITE Stock Cleaning / Disinfecting Solution are detailed on the labeling, as required by FDA regulations. While the exact specifics (e.g., temperature, light exposure) are not provided here, the solution adheres to standard ophthalmic product guidelines to ensure efficacy and safety. Always refer to the labeling for precise storage instructions and expiration dates.

• What regulatory pathway does this device follow, and what does that mean for its use?

  The BRITE Stock Cleaning / Disinfecting Solution follows the FDA Premarket Approval (PMA) pathway, with PMA number P870023, and is classified as a Class II device under OpenFDA. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use in ophthalmic settings, particularly for cleaning and disinfecting lens cases and stock solutions. The approval ensures compliance with regulatory standards like 21 CFR 886.5928 for soft lens accessories.

• Are there different sizes or models of this solution available, or is it supplied in a single formulation?

  The provided data does not specify distinct sizes or models of the BRITE Stock Cleaning / Disinfecting Solution beyond its classification as a liquid solution for manual application. However, the multiple FEI numbers (e.g., 3006140792, 3012236936) listed under registration suggest there may be variations in packaging or formulations, though these are not detailed in the description. For exact sizes or model-specific details, consult the labeling or manufacturer documentation.