DEVICE: LOTUS Ⅱ power cable (08800035500238)

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Device Record History
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Device Identifier (DI) Information
LOTUS Ⅱ power cable
LOTUS Ⅱ power cable
In Commercial Distribution

Laseroptek Co.,Ltd
08800035500238
GS1

1
689856875 *Terms of Use
LOTUS Ⅱ power cable
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36170 General/multiple surgical solid-state laser system
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEX Powered Laser Surgical Instrument
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K083253 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
18d5efd0-e5f4-4008-842c-2e93fc5e7059
July 06, 2018
3
January 12, 2018
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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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