DEVICE: TIP for LITETOUCH (07290016784060)

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Device Record History
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Device Identifier (DI) Information
TIP for LITETOUCH
ENDO
In Commercial Distribution
LI-FG4001(X)
LIGHT INSTRUMENTS LTD
07290016784060
GS1

5
514489314 *Terms of Use
Package of 5 single-use tips for the LITETOUCH system
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
47880 Dental 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 application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.
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 [?]
K061966 000
No CLOSE

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
4b5b2f86-550a-4851-a1d9-6ff0aa3caa86
December 09, 2022
1
December 01, 2022
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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: 37290016784061 CLOSE

Direct Marking (DM)

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

[?]
No
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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