MEL 80

GUDID 04049471000221

The MEL 80 Excimer Laser System is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or eliminat

Carl Zeiss Meditec AG

Ophthalmic excimer laser system
Primary Device ID04049471000221
NIH Device Record Key7819b6e3-b608-4afa-be04-8838d35be1a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEL 80
Version Model NumberMEL 80
Company DUNS314594680
Company NameCarl Zeiss Meditec AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Weight260 Kilogram
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104049471000221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZSExcimer Laser System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-03

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