Charter Labs Saline Solution

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

Generic Name

Accessories, soft lens products

PMA Number

P840069 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S004 (Normal 180 Day Track)

• Bandage

  Class I

  FDA 510(k) K761093 Active Cleared 6 Jan 1977

• Charter Wetting Solution for Hard Contact Lenses

  Unclassified

  FDA 510(k) K862952 Active Cleared 25 Sep 1986

• Sterile Saline Solution

  Class I

  FDA 510(k) K843797 Active Cleared 18 Jan 1985

• Charter Laboratories Inc. Lens Lubricant

  Unclassified

  FDA 510(k) K863974 Active Cleared 10 Nov 1986

• Sterile Water

  Not classified

  FDA 510(k) K843796 Active Cleared 10 Dec 1984

• Charter Hard Contact Lens Cleaning Solution

  Unclassified

  FDA 510(k) K865111 Active Cleared 20 Jan 1987

See all devices from Paco Pharmaceutical Services, Inc. →

• What is the primary purpose of the Charter Labs Saline Solution, and how does it differ from regular saline solutions?

  The Charter Labs Saline Solution is specifically designed for ophthalmic use, serving as a sterile solution for cleaning, rinsing, or storing soft contact lenses. Unlike regular saline solutions, it is formulated to maintain lens hygiene and integrity without compromising the lens material, ensuring safe and effective contact lens care.

• Is the Charter Labs Saline Solution intended for single-use or multi-use applications, and how should it be stored?

  The Charter Labs Saline Solution can be supplied as either single-use or multi-use, depending on the specific formulation and packaging. While the data does not specify storage conditions beyond sterility, standard practice for saline solutions typically requires storage in a cool, dry place away from direct sunlight to preserve sterility and effectiveness.

• What regulatory pathway was followed for the approval of this device, and what class does it fall under?

  The Charter Labs Saline Solution was approved through the FDA’s Premarket Approval (PMA) process under PMA number P840069. It is classified as a Class II medical device under regulation number 886.5928, which is the standard regulatory route for accessories like soft lens products.

• Are there different sizes or models of the Charter Labs Saline Solution, and how would I identify the correct one for my needs?

  The Charter Labs Saline Solution is available in multiple formulations, as indicated by the various FEI numbers (e.g., 3006140792, 3012236936, etc.), which correspond to different product codes under the LPN category. While the exact sizes or packaging variations aren’t detailed, the manufacturer likely offers options to suit single-use or multi-use applications—check the labeling or consult the manufacturer for the specific formulation matching your contact lens care routine.