Applied Laboratories Sterile Saline Solution

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Accessories, soft lens products

PMA Number

P870002 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

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• GE Noryl 731-80089S Contact Lens Case

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  FDA 510(k) K873821 Active Cleared 24 Mar 1988

See all devices from Applied Laboratories, Inc. →

• What is the primary use of the Applied Laboratories Sterile Saline Solution in clinical settings?

  This sterile saline solution is specifically designed for ophthalmic use as an irrigation solution. It is intended for cleaning, rinsing, and storing soft contact lenses to help maintain hygiene and ensure comfort for patients.

• Is the Applied Laboratories Sterile Saline Solution intended for reuse, or is it meant for single-use only?

  The device is explicitly labeled as a sterile, single-use product. This ensures that each container is intended for one-time use only, maintaining sterility and safety for direct contact with ocular tissues.

• What regulatory pathway does the Applied Laboratories Sterile Saline Solution follow, and what does this mean for its use?

  The solution is regulated under the FDA Premarket Approval (PMA) pathway with PMA number P870002. This means it has undergone rigorous review to ensure safety and effectiveness for its intended ophthalmic use as an accessory for soft contact lenses.

• How is the sterility of the Applied Laboratories Sterile Saline Solution maintained, and why is this important?

  The solution is packaged in sterile containers, which ensures that it remains uncontaminated and safe for direct contact with ocular tissues. Sterility is critical in ophthalmic applications to prevent infections and maintain patient safety.

• Are there different sizes or models of the Applied Laboratories Sterile Saline Solution, or is it available in a single formulation?

  The provided data does not specify varying sizes or models, but the solution is classified under product code LPN and is intended as a sterile saline solution for ophthalmic use. For exact packaging details, such as volume per container, refer to the manufacturer’s labeling or product documentation.