Minitheerm Soft Contact Lenses

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

Full name

Minitheerm

Generic Name

Lenses, soft contact, daily wear

PMA Number

N18001 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

• 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

• 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 →

• Are these contact lenses designed for overnight wear, or are they strictly for daily use only?

  The Minitheerm lenses are explicitly classified as daily wear, meaning they are intended for use during waking hours only and are not approved for overnight or extended wear. Since they are disposable, they are meant to be discarded after a single day of use without cleaning or disinfection.

• How are the Minitheerm lenses packaged, and what does this mean for clinical or home use?

  The Minitheerm lenses are supplied in sterile, single-use packaging, ensuring immediate readiness for application without the need for additional sterilization. This design makes them convenient for both clinical settings (e.g., eye care offices) and home use, as each lens is pre-sterilized and ready to wear right out of the package.

• Can these lenses be reused, or are they strictly for single-use only?

  The Minitheerm lenses are intended for single-use only and are not designed for reuse. Their disposable nature eliminates the need for cleaning or disinfection between uses, which aligns with their classification as daily-wear contact lenses. Reusing them would violate their intended use and could compromise safety or comfort.

• What regulatory pathway was followed for the approval of the Minitheerm lenses, and what does this imply about their oversight?

  The Minitheerm lenses were approved through the FDA Premarket Approval (PMA) pathway, designated as PMA N18001, and fall under FDA regulation 886.5925 with a product code of LPL. This classification indicates they are subject to Class II regulatory standards, meaning they undergo rigorous review to ensure safety and effectiveness for their intended use as disposable, daily-wear soft contact lenses.

• Are there multiple sizes or models of Minitheerm lenses, or is this a one-size-fits-all product?

  The Minitheerm lenses are available in multiple sizes and models, as indicated by the extensive list of FEI numbers (e.g., 3015533540, 3012546757, etc.) in the data. These identifiers correspond to different lens specifications (e.g., base curve, diameter, or power) to accommodate various prescriptions and corneal shapes. Clinicians should consult the manufacturer’s sizing guides to select the appropriate model for each patient.