Visulas 532S

• • Terminated Z-1066-04 FDA Unclassified (pre-2012) ·initiated 3 Jun 2004

  The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on the eye. Retinal bleeding and burns may result.

510(k) Number

K013402 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical application for the VISULAS 532S?

  The VISULAS 532S is a diode-pumped solid-state laser workstation intended for single-spot treatment in clinical settings. It is specifically indicated for addressing conditions such as diabetic retinopathy and diabetic maculopathy.

• How is the laser system cooled during operation?

  The system is designed as a fully integrated laser workstation that includes a built-in thermoelectric cooling system to manage thermal output during clinical use.

• What is the regulatory status of the VISULAS 532S?

  The VISULAS 532S has received FDA 510k clearance for its intended use as a laser workstation. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

• Where can the VISULAS 532S be utilized?

  This laser workstation is designed for use in various clinical environments, including outpatient retina clinics and operating rooms, to support ophthalmic procedures.