SQUARE EPIL ALEX + Nd:YAG

GUDID 08052049500029

BIOS SRL

Dermatological solid-state laser system
Primary Device ID08052049500029
NIH Device Record Key03527cd9-7c92-46d5-8fce-075b047aff92
Commercial Distribution StatusIn Commercial Distribution
Brand NameSQUARE EPIL ALEX + Nd:YAG
Version Model NumberAPMD122.US
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
GS108052049500029 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2017-02-15

Devices Manufactured by BIOS SRL

08052049500289 - OptiPLUS2023-11-14
08052049500272 - OptiPLUS2023-08-31
08052049500227 - OptiStream2022-10-12
08052049500210 - NUERA TIGHT 1ch Paris Edition2022-07-14
08052049500135 - FEMINESS tip2021-11-10
08052049500197 - FEMINESS2021-11-10
08052049500012 - SUPERBIUM2021-08-24
08052049500005 - THERMI 2502020-11-30

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