Osept(R) & Lensept(R) Solutions

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

Trade Name

Septicon(Tm) Disinfection Regimen for Use with

Generic Name

Accessories, soft lens products

PMA Number

P820040 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S004

• 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 →

• What is the purpose of OSEPT(R) & LENSEPT(R) SOLUTIONS?

  These solutions are designed to clean, disinfect, and store soft contact lenses to maintain hygiene and prevent microbial contamination, adhering to ophthalmic standards for lens care.

• How are OSEPT(R) & LENSEPT(R) SOLUTIONS supplied?

  The solutions are supplied as a sterile, single-use or multi-use regimen for use in ophthalmic settings, packaged for clinical or home use to ensure compliance with ophthalmic disinfection protocols.

• Are OSEPT(R) & LENSEPT(R) SOLUTIONS single-use or reusable?

  The solutions can be used as either a single-use or multi-use regimen, as indicated by the SEPTICON disinfection regimen, depending on the user's preference and needs.

• What regulatory status do OSEPT(R) & LENSEPT(R) SOLUTIONS have?

  The solutions are regulated under FDA Premarket Approval (PMA) with the designation P820040 and fall under regulation number 886.5928, ensuring they meet safety and efficacy standards.