Zeiss Visulas Diode Laser

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K923274 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• S 21 Instrument Stand

  Class I

  FDA 510(k) K883578 Active Cleared 13 Sep 1988

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  Class II

  FDA 510(k) K920529 Active Cleared 2 Apr 1992

• Zeiss 20 Sl Slit-Lamp & Mechanical Micromanipulatr

  Class II

  FDA 510(k) K925641 Active Cleared 9 Sep 1993

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  FDA 510(k) K891584 Active Cleared 8 Jun 1989

• Opmi Twiner Surgical Microscope

  Class II

  FDA 510(k) K983868 Active Cleared 29 Jan 1999

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  FDA 510(k) K924588 Active Cleared 9 Jul 1993

See all devices from Carl Zeiss, Inc. →

• What is the Zeiss Visulas Diode Laser used for?

  The Zeiss Visulas Diode Laser is used in various applications, including photocoagulation, and is available with specific models such as the Visulas 532s, indicating its versatility in therapeutic treatments.

• Is the Zeiss Visulas Diode Laser authorized by regulatory bodies?

  The Zeiss Visulas Diode Laser has received FDA 510K authorization, indicating that it has been reviewed and cleared for use in therapeutic settings.

• What are the specifications of the Zeiss Visulas Diode Laser?

  The Zeiss Visulas Diode Laser has a product code of GEX and is classified as substantially equivalent, with a clearance type of traditional, providing assurance of its safety and efficacy.