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Laserscan LSX Excimer Laser System

by Lasersight Technologies, Inc.

PMA P980008

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P980008↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP980008 Date12 Nov 1999ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Laserscan Lsx Excimer Laser
Trade Name
Laserscan Lsx Excimer Laser System
Generic Name
Excimer laser system
PMA Number
FDA Product Code
LZS
Device Class
Class III
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved

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 Laserscan LSX Excimer Laser System is an excimer laser device classified as a Class III medical device, designed for myopic photorefractive keratectomy. It is intended to reshape the cornea to reduce or eliminate myopia, correcting refractive errors ranging from -1.0 to less than -6.0 diopters with up to 1.0 diopter of astigmatism.

This system is used in ophthalmic settings under controlled conditions, typically by trained surgeons. It is supplied as a reusable device with FDA approval (PMA P980008) and is regulated under the advisory committee for ophthalmic procedures. The device requires proper calibration, maintenance, and adherence to sterile protocols to ensure safe clinical use.

Other devices from Lasersight Technologies, Inc.