MEL 80

Basic Information

• Brand Name: MEL 80
• Primary DI: 04049471000221
• Version / Model: MEL 80
• Company Name: Carl Zeiss Meditec AG
• Labeler DUNS: 314594680
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-03
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7819b6e3-b608-4afa-be04-8838d35be1a7

Device Description

The MEL 80 Excimer Laser System is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of - myopia of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D, with a Maximum MRSE of -7.0 D - naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of greater than +0.5 D and less than or equal to +3.0 D, with a maximum MRSE of +5.0 D in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by Change in sphere and cylinder of 0.5 D.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZS	Excimer Laser System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
17702	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049471000221	GS1

Premarket Submissions

Submission Number	Supplement Number
P060004	001

Device Sizes

Type	Value	Unit	Text
Weight	260	Kilogram
Device Size Text, specify			LxWxH: 1.55m x 0.80m x1.49m

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -15 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 50 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 18 – 24 Degrees Celsius