Murine Contact Lens Cleaner
by Abbott Laboratories PMA
Active
PMA P880052
Overview
The Murine Contact Lens Cleaner is a soft lens accessory designed for the cleaning and maintenance of contact lenses. Classified under accessories for soft lens products, it is intended to remove debris and proteins from lenses to ensure proper hygiene and comfort during wear.
This device is supplied as a non-sterile solution for single-use per lens. It is regulated under FDA Premarket Approval (PMA) with PMA number P880052 and falls under regulation number 886.5928. The product is intended for use in ophthalmic settings and is packaged for individual lens cleaning, adhering to standard contact lens care protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP880052 | Date10 Jul 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Accessories, soft lens products
- PMA Number
- FDA Product Code
- LPN
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001 (Normal 180 Day Track)
Other devices from Abbott Laboratories
Questions
What is the Murine Contact Lens Cleaner specifically designed to do for contact lenses?
The Murine Contact Lens Cleaner is designed to remove debris and proteins from soft contact lenses, helping to maintain proper hygiene and ensure comfort during wear. It follows standard contact lens care protocols to keep lenses clean between uses.
Is this solution intended for single-use or repeated use on the same lens?
The Murine Contact Lens Cleaner is supplied as a non-sterile solution for single-use per lens. This means each lens should use a fresh application of the cleaner to maintain proper hygiene and effectiveness.
How is the Murine Contact Lens Cleaner regulated by the FDA, and what does that mean for its use?
The Murine Contact Lens Cleaner is regulated under FDA Premarket Approval (PMA) with PMA number P880052, indicating it has undergone rigorous review for safety and effectiveness. This classification ensures it meets strict standards for use in ophthalmic settings as an accessory for soft lens maintenance.
Does this product come in multiple sizes or models, or is it a single formulation?
The provided data does not specify varying sizes or models of the Murine Contact Lens Cleaner. It is classified under accessories for soft lens products and is packaged for individual lens cleaning, adhering to standard protocols without additional size variations mentioned.
What storage considerations should be kept in mind for the Murine Contact Lens Cleaner?
Since the Murine Contact Lens Cleaner is non-sterile and intended for single-use per lens, it should be stored in a cool, dry place away from direct sunlight to preserve its effectiveness. Always check the packaging for expiration dates and ensure the solution remains uncontaminated before use.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P880052