LaseMD Ultra

GUDID 08809447653129

Handpiece stand

Lutronic Corporation

Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system
Primary Device ID08809447653129
NIH Device Record Key3fd5eb0c-7f21-4182-80e7-74ccca08dd3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaseMD Ultra
Version Model NumberHandpiece stand Assy
Company DUNS688282516
Company NameLutronic Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809447653129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-18
Device Publish Date2020-09-10

On-Brand Devices [LaseMD Ultra]

08809447653990Optic_Goggle (Doctor)
08809447654010Wire Remote Interlock Key
08809447653099ASSY_TIP_C5
08809447653082BLISTERED COMB SET_LaseMD Ultra
08809447653075BLISTERED SQUARE SET_LaseMD Ultra
08809447653068BLISTERED ROLLER SET_LaseMD Ultra
08809447653044LaseMD Ultra U120V
08809447653204LaseMD Ultra U120V case
08809447653198cap_incubator
08809447653181Patient goggle
08809447653150AC POWER CABLE 3m
08809447653143Foot Switch
08809447653136LaseMD Ultra Operator's Manual for USA
08809447653129Handpiece stand
08809447653112Handpiece holder
08809447653105HANDPIECE ASSY_LaseMD Ultra

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