DEVICE: WAVELIGHT EX500 EXCIMER LASER (00380659907944)

Device Identifier (DI) Information

WAVELIGHT EX500 EXCIMER LASER
8065990794
In Commercial Distribution
8065990794
Alcon Laboratories, Inc.
00380659907944
GS1

1
008018525 *Terms of Use
WAVELIGHT EX500 EX LASER US
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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.
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FDA Product Code

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Product Code Product Code Name
LZS Excimer Laser System
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FDA Premarket Submission

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

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Weight: 1200 Pound
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Device Record Status

35057b0a-3a06-4173-9d96-f5c655d80948
July 06, 2018
3
September 24, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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+1(800)-862-5266
web.masterus@alcon.com
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