Splendor X

GUDID 08052049500265

BIOS SRL

Dermatological solid-state laser system
Primary Device ID08052049500265
NIH Device Record Key17cde336-8a0c-4aa6-8c57-efc1b22e5300
Commercial Distribution StatusIn Commercial Distribution
Brand NameSplendor X
Version Model NumberSplendor X Nd:YAG
Company DUNS443571203
Company NameBIOS SRL
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108052049500265 [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 Date2024-07-10
Device Publish Date2024-07-02

On-Brand Devices [Splendor X]

08052049500265Splendor X Nd:YAG
08052049500258Splendor X Alex2
08052049500241Splendor X Alex
08052049500234Splendor X Alex+Nd:YAG

Trademark Results [Splendor X]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPLENDOR X
SPLENDOR X
88975165 5745686 Live/Registered
Lumenis Ltd.
2018-10-02
SPLENDOR X
SPLENDOR X
88140383 not registered Live/Pending
Lumenis Ltd.
2018-10-02

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