Salt Tablets

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

Generic Name

Accessories, soft lens products

PMA Number

P810015 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S003

• In a Wink Lubricating & Rewetting Drops

  Unclassified

  FDA 510(k) K853445 Active Cleared 29 Nov 1985

• Professional Disinfection System (Pds)

  Class II

  FDA 510(k) K863346 Active Cleared 27 Feb 1987

• Ciba Vision Lens Drops

  Class II

  FDA PMA P860060 Active Approved 8 Aug 1988

• Minitheerm Soft Contact Lenses

  Class II

  FDA PMA N18001 Active Approved 8 Aug 1979

• SoftCon (Vifilcon A) Soft Contact Corrective Lens

  Class II

  FDA PMA N17554 Active Approved 1 Jul 1985

• Tresoft Soft Contact Lenses

  Class II

  FDA PMA N17855 Active Approved 2 Oct 1979

See all devices from Ciba Vision Care →

• What is the primary purpose of these salt tablets in contact lens care routines?

  These salt tablets are designed to create a sterile saline solution when dissolved in water, which is specifically intended for cleaning and disinfecting soft contact lenses. They help maintain proper lens hygiene during maintenance, ensuring lenses remain safe for patient use.

• Are these salt tablets intended for single-use or reusable applications?

  The salt tablets can be used either as a single-use component or as a reusable solution base, depending on the context of use. When dissolved in water, they form a saline solution suitable for repeated cleaning and disinfection cycles of soft contact lenses, provided sterile procedures are followed.

• How should these salt tablets be stored to ensure their effectiveness?

  While the data does not specify storage conditions explicitly, since these tablets are intended to create a sterile saline solution for ophthalmic use, they should be stored in a clean, dry environment away from direct sunlight and moisture. Proper storage ensures the tablets remain viable for dissolving in water when needed.

• What regulatory pathway was followed for the approval of these salt tablets?

  These salt tablets were approved through the FDA’s Premarket Approval (PMA) process, with the designation P810015 under regulation number 886.5928. The approval was granted in 1982, as indicated by the decision date, and they fall under the classification of Accessories, Soft Lens Products for ophthalmic use.

• Are these salt tablets compatible with all types of soft contact lenses?

  The tablets are specifically designed for soft contact lenses and are intended to provide a saline solution for cleaning and disinfecting. While they are likely compatible with most soft lenses, users should always refer to the lens manufacturer’s instructions to confirm compatibility, as some lens materials or care systems may have specific requirements.