MEL 90

Primary DI
04049471095074
Brand
MEL 90
Company
Carl Zeiss Meditec AG
Model
1900-109
Device description
The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter.Indications for Use:The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of:• Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D;• Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and• Mixed astigmatism with cylinder from >1.00 D up to 4.00 D;in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.
Published
2024-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LZSExcimer Laser System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZSExcimer Laser SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060004006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060004006MEL 80 EXCIMER LASER SYSTEMCarl Zeiss Meditec, Inc.2006-08-11LZS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049471095074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049471095074040494710950744049471095074

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic excimer laser systemA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight295Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius24 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314594680
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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04049471091496VISULASVISULAS combi2026-01-12
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04049471090260AT 030AT 0302018-12-04
04049471091229VISULAS TrionVISULAS Trion, VISULAS Trion VITE2016-09-20
04049471091403VISULAS 532sVISULAS 532s, VISULAS 532s VITE2016-09-20
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04049539072139QEVO ECU72132017-08-24
04049539105509INTRABEAM Spherical Sizer Set309121-9100-0002025-06-20
04049539105516INTRABEAM SMART Spherical Applicator309120-9015-002025-05-14
04049539105523INTRABEAM SMART Spherical Applicator 309120-9020-0002025-05-14
04049539105530INTRABEAM SMART Spherical Applicator 309120-9025-0002025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)309120-9035-0002025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)309120-9035-0002025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)309120-9040-0002025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)309120-9045-0002025-05-14
04049539101563INTRABEAM® Spherical Applicator 1.5 cm304534-6000-5572017-04-14
04049539101570INTRABEAM® Spherical Applicator 2.0 cm304534-6000-5582017-04-14
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Primary DI, Brand, Company table
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05050474651432IDESIGN RSJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2018-08-15
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05050474573413STAR S4 IRJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2014-11-28
05050474573444WAVESCAN WAVEFRONT SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2014-11-20
05050474591905WAVESCAN OFFLINE PROGRAMMING MODULEJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2014-11-14
00380659906060WAVELIGHT REFRACTIVE SUITEAlcon Laboratories, Inc.LZS2014-09-24
00380659907463WAVELIGHT REFRACTIVE SUITEAlcon Laboratories, Inc.LZS2014-09-24
00380659907678WAVELIGHT ALLEGRO TOPOLYZERAlcon Laboratories, Inc.LZS2014-09-24
00380659907944WAVELIGHT EX500 EXCIMER LASERAlcon Laboratories, Inc.LZS2014-09-24
00380659908170WAVENETAlcon Laboratories, Inc.LZS2014-09-24
00380659908965WAVELIGHT REFRACTIVE SUITEAlcon Laboratories, Inc.LZS2014-09-24
04987669100011NANIDEK CO.,LTD.LZS2014-09-15
04987669100028Quest™NIDEK CO.,LTD.LZS2014-09-15
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