AccessGUDID - DEVICE: WAVELIGHT EX500 EXCIMER LASER (00380659907944)

GUDID

Device Identifier (DI) Information

Brand Name: WAVELIGHT EX500 EXCIMER LASER
Version or Model: 8065990794
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8065990794
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380659907944
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: WAVELIGHT EX500 EX LASER US

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Ophthalmic excimer laser system	A mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power laser beam intended for corneal ablation (i.e., photorefractive keratectomy) and other ophthalmologic procedures (e.g., surgical creation of a communication between the lacrimal sac and the nasal cavity). It includes a light source and controls/foot-switch, and is typically coupled to a biomicroscope slit lamp or to an indirect ophthalmoscope by a flexible fibreoptic cable. It does not include femtosecond pulsing or fundus imaging technology.

GMDN Preferred Term Name

GMDN Definition

Ophthalmic excimer laser system

A mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power laser beam intended for corneal ablation (i.e., photorefractive keratectomy) and other ophthalmologic procedures (e.g., surgical creation of a communication between the lacrimal sac and the nasal cavity). It includes a light source and controls/foot-switch, and is typically coupled to a biomicroscope slit lamp or to an indirect ophthalmoscope by a flexible fibreoptic cable. It does not include femtosecond pulsing or fundus imaging technology.

FDA Product Code

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Product Code	Product Code Name
LZS	Excimer Laser System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020050	000
P030008	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Weight: 1200 Pound

Device Record Status

Public Device Record Key: 35057b0a-3a06-4173-9d96-f5c655d80948
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2014