Cibatint Tinting Process

• • Terminated Z-0793-2007 FDA Unclassified (pre-2012) ·initiated 30 Apr 2007

  Base curve of the lenses do not meet specification.

• • Terminated Z-0342-03 FDA Unclassified (pre-2012) ·initiated 12 Nov 2002

  Lenses were labeled with the wrong prescription.

Full name

Cibatint(Tm) Tinting Process

Generic Name

Lenses, soft contact, daily wear

PMA Number

P820086 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S004

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  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

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  FDA PMA P860060 Active Approved 8 Aug 1988

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  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 Cibatint Tinting Process used for in clinical settings?

  The Cibatint Tinting Process is designed to apply a tint to soft contact lenses intended for daily wear. It enhances visual comfort or aesthetic appearance under professional guidance, such as by ophthalmologists or optometrists, rather than serving a therapeutic function.

• Is the Cibatint Tinting Process intended for single-use or reusable applications?

  The Cibatint Tinting Process is supplied as a reusable system for tinting lenses in clinical or manufacturing settings. It is explicitly not intended for single-use, meaning it can be used repeatedly for multiple tinting procedures.

• What regulatory pathway does the Cibatint Tinting Process follow, and what does this mean for its use?

  The Cibatint Tinting Process follows the FDA Premarket Approval (PMA) pathway, indicated by PMA number P820086. This means the device has undergone rigorous review by the FDA to ensure safety and effectiveness before being authorized for commercial distribution. The approval covers its use for tinting soft contact lenses under the specified conditions.

• Are there any specific storage requirements mentioned for the Cibatint Tinting Process?

  The provided data does not specify any particular storage conditions, such as temperature or environmental requirements, for the Cibatint Tinting Process. However, since it is a reusable system, proper cleaning and maintenance per manufacturer guidelines would be necessary to ensure safe and effective use.

• How is the Cibatint Tinting Process supplied, and is it sterile?

  The Cibatint Tinting Process is supplied as a reusable system for tinting lenses in clinical or manufacturing environments. It is explicitly stated as not sterile, meaning it is not intended for direct patient contact without additional processing or sterilization steps.