MOSAIC 3D

GUDID 08809447657011

MOSAIC 3D

Lutronic Corporation

Dermatological solid-state laser system
Primary Device ID08809447657011
NIH Device Record Key0e10afa5-604b-45f7-9a2d-abaf1e12532a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOSAIC 3D
Version Model NumberMOSAIC 3D
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108809447657011 [Primary]

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 Date2025-12-08
Device Publish Date2025-11-28

On-Brand Devices [MOSAIC 3D]

08809447657448Sapphire Tip (S10 Tip) Package
08809447657394Sapphire Tip (S20 Tip) Package
08809447656960Pill Tip Package (Pill Tip 4ea)
08809447657417Comb Tip Package (Comb Tip 4ea)
08809447657387Roller Tip Package (Roller Tip 4ea + Roller Set 4set)
08809447657370Sapphire Tip Package(S20 Tip 2ea + S10 Tip 2ea) (S20 Tip Unit of Use DI Number : 08809447657431,
08809447657011MOSAIC 3D

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.