DEVICE: TIP for LITETOUCH (07290016784374)
Device Identifier (DI) Information
TIP for LITETOUCH
D-1.3mm L-14mm
In Commercial Distribution
AS70662
LIGHT INSTRUMENTS LTD
D-1.3mm L-14mm
In Commercial Distribution
AS70662
LIGHT INSTRUMENTS LTD
Package of 5 reusable tips for the LiteTouch system
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? |
---|---|---|---|---|
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEX | Powered Laser Surgical Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K061966 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Lumen/Inner Diameter: 1.3 Millimeter |
Length: 14 Millimeter |
Device Record Status
558435bf-313e-440c-a5ca-137abb63f6f1
July 06, 2018
3
January 01, 2017
July 06, 2018
3
January 01, 2017
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
37290016784375
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+972-732563202
Office@light-inst.com
Office@light-inst.com