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Visulas Nd:Yag Laser

by Carl Zeiss, Inc. PMA

Active United States

PMA P850083

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP850083 Date5 Oct 1987ApprovedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Generic Name
Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
PMA Number
FDA Product Code
LOI
Device Class
Class III
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S006 (Normal 180 Day Track)

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Visulas Nd:Yag Laser is a neodymium:YAG ophthalmic laser designed for uses other than posterior capsulotomy and cutting the pupillary membrane. It is classified as a Class III medical device under the OpenFDA nomenclature, intended for specific intraocular applications in ophthalmology.

This device is supplied by Carl Zeiss, Inc. and is regulated under an FDA Premarket Approval (PMA) with PMA number P850083. It is intended for single-use or reusable settings as indicated in the approved labeling, with no explicit mention of MRI safety or sterility requirements in the provided data. Storage and handling instructions are detailed in the approved labeling, which may include shelf-life considerations.

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