Visulas YAG II

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K003885 ↗

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 specific ophthalmic procedures is the Visulas YAG II laser designed to perform, and how does it improve patient outcomes in those cases?

  The Visulas YAG II is specifically designed for photodisruption procedures, including posterior capsulotomy (removing cloudy tissue behind an intraocular lens) and iridotomy (creating an opening in the iris to improve fluid drainage and reduce intraocular pressure). These procedures enhance IOL visibility and patient vision by clearing obstructions that can develop over time after cataract surgery or in conditions like narrow-angle glaucoma. Its 4-point aiming beam and adjustable offset controls allow for precise targeting, reducing the risk of complications like lens damage or retinal injury.

• Is the Visulas YAG II laser itself sterile, or does it require additional sterile accessories for patient use?

  The Visulas YAG II laser system itself is non-sterile and operates in a clean, non-patient-contact environment. However, sterile application accessories (such as handpieces, fibers, or contact lenses) are required for direct interaction with the patient’s eye. These accessories must be sterilized before use to maintain aseptic conditions during procedures like capsulotomy or iridotomy.

• How is the Visulas YAG II supplied, and what key features distinguish it from other Nd:YAG laser systems?

  The Visulas YAG II is supplied as a standalone laser workstation, meaning it includes all necessary components (including controls and aiming systems) in a single unit for clinical use. Key distinguishing features include its patented 4-point aiming beam, which improves precision during procedures, and ergonomic controls for easier handling. Additionally, it offers adjustable anterior/posterior offset options, allowing surgeons to fine-tune targeting depth for procedures like iridotomy or capsulotomy, which may vary based on patient anatomy.

• What regulatory pathway was followed for FDA clearance of the Visulas YAG II, and which advisory committee reviewed the submission?

  The Visulas YAG II received FDA 510(k) clearance under the Subcommittee for Urology (SU), with a decision date of February 22, 2001. The submission was classified as Substantially Equivalent (SESE) to a predicate device, and the review was conducted under the General, Plastic Surgery advisory category. This pathway confirms the device’s compliance with FDA standards for surgical, ophthalmic lasers used in procedures like capsulotomy and iridotomy.