Visitec Silicone Retinal Implants/Explants

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K945172 ↗

FDA Product Code

HQX

Device Class

Class II

Regulation

21 CFR Part 886.3340

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Visitec Ophthalmic Aspiration Unit Model 100

  Class II

  FDA 510(k) K853961 Active Cleared 13 Dec 1985

• Visi-Wipe

  Class I

  FDA 510(k) K884924 Active Cleared 31 Jan 1989

• Micro Surgical Handle

  Class I

  FDA 510(k) K831996 Active Cleared 12 Jul 1983

• Visitec Canalicular Stent

  Unclassified

  FDA 510(k) K915809 Active Cleared 24 Feb 1992

• Visitec Collar Button Catheter {griffiths}

  Unclassified

  FDA 510(k) K953394 Active Cleared 12 Oct 1995

• Visi-Sorb Absorbant Stick

  Class II

  FDA 510(k) K900786 Active Cleared 18 May 1990

See all devices from Visitec Co. →

• What are the Visitec Silicone Retinal Implants/Explants used for?

  The Visitec Silicone Retinal Implants/Explants are ophthalmic devices designed for retinal applications and are classified as implants for orbital and extra-ocular use. They are manufactured by Visitec Co. and come in various sizes to accommodate different clinical needs.

• Are these devices single-use or reusable?

  The Visitec Silicone Retinal Implants/Explants can be either single-use or multiple-use depending on the specific model. The sterility status is not specified in the provided data, so users should refer to the specific product information for details on sterility and intended use.

• What sizes and models of Visitec Silicone Retinal Implants/Explants are available?

  The devices are supplied in various sizes as indicated by multiple FEI numbers including 1218813, 3002991496, 3002532015, 3009337401, 3002445546, 1220477, 3004467263, 3000314405, 3006003617, 3002806863, 3002807041, 3002807111, and 1000286794. Each size may have different specifications and intended applications.

• What is the regulatory status of these implants?

  The Visitec Silicone Retinal Implants/Explants are regulated under FDA 510K clearance with a product code of HQX. They are classified as Class II devices and received traditional clearance with a decision code of SESE (Substantially Equivalent) on January 17, 1995.