DEVICE: ATL (06970507240206)

Device Identifier (DI) Information

ATL
GlobalCure-SC6
In Commercial Distribution

Advanced Technology Laser Co.,Ltd.
06970507240206
GS1

1
547070719 *Terms of Use
No description.
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Device Characteristics

MR Unsafe
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dermatological 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 to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing and lesion/hair/tattoo removal; it may also be used for coagulation/haemostasis procedures. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch; it does not include frequency-doubling technology.
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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 [?]
K102050 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

1e0a83c3-050c-4695-95bf-36014243d6de
July 06, 2018
3
October 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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