DEVICE: WAVELIGHT REFRACTIVE SUITE (00380659907463)

Device Identifier (DI) Information

WAVELIGHT REFRACTIVE SUITE
8065990746
In Commercial Distribution

Alcon Laboratories, Inc.
00380659907463
GS1

1
008018525 *Terms of Use
REFRACTIVE SUITE SWIVEL BED
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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 chair, line-powered A mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table).
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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 006
P030008 006
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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: 800 Pound
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Device Record Status

c1661a28-531f-4dae-9322-55e28041dc49
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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No Customer Contact currently defined
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