Tresoft Soft Contact Lenses

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

Full name

Tresoft Soft Contact Lense

Generic Name

Lenses, soft contact, daily wear

PMA Number

N17855 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

• 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

• Salt Tablets

  Class II

  FDA PMA P810015 Active Approved 6 Aug 1982

• 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

See all devices from Ciba Vision Care →

• Are these contact lenses designed for extended wear, or are they meant to be worn only during the day?

  The Tresoft Soft Contact Lenses are explicitly labeled as daily wear, meaning they are intended for use during waking hours only and should not be worn overnight. This classification ensures they are safe for typical daytime vision correction without the risks associated with extended or continuous wear.

• How are these lenses supplied, and do they require any special handling before use?

  The Tresoft Soft Contact Lenses are supplied as single-use, non-reusable devices, meaning each lens is intended for one-time use only. They are also sterile and designed for clinical application by trained professionals, so they should be handled in a sterile manner to maintain integrity and safety before insertion.

• What regulatory pathway was followed for approval, and how does this affect their use in clinical settings?

  These lenses were authorized through the FDA Premarket Approval (PMA) process under regulation number 886.5925, with the product code LPL. This pathway ensures rigorous evaluation of safety and effectiveness, making them suitable for clinical use by trained ophthalmic professionals in sterile conditions. The PMA status confirms their compliance with stringent regulatory standards.

• Are there multiple sizes or models available for these contact lenses, or is there a single standard fit?

  While the provided data does not specify exact sizes or models in plain terms, the OpenFDA registration numbers and FEI numbers listed indicate multiple variants (e.g., 3015533540, 3012546757, etc.) are approved under this trade name. This suggests the lenses may come in different prescriptions or diameters to accommodate various refractive errors and corneal fits, though exact details would require consulting the manufacturer’s catalog or specifications.