Diode 755nm Alex Applicator for Soprano Titanium (Black) AASP28012401

GUDID 17290110123526

Diode 755nm Alex Applicator for Soprano Titanium (Black)

ALMA LASERS LTD.

Dermatological diode laser system
Primary Device ID17290110123526
NIH Device Record Key6bbfb98f-379b-47f0-bfe2-01f03f0da138
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiode 755nm Alex Applicator for Soprano Titanium (Black)
Version Model Number1
Catalog NumberAASP28012401
Company DUNS532283264
Company NameALMA LASERS LTD.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290110123526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-25
Device Publish Date2024-03-17

Devices Manufactured by ALMA LASERS LTD.

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07290110123611 - TED Applicator2024-09-23 TED Applicator
17290110123526 - Diode 755nm Alex Applicator for Soprano Titanium (Black)2024-03-25Diode 755nm Alex Applicator for Soprano Titanium (Black)
17290110123526 - Diode 755nm Alex Applicator for Soprano Titanium (Black)2024-03-25 Diode 755nm Alex Applicator for Soprano Titanium (Black)
07290110123451 - ClearVas2024-02-26
07290110123468 - ClearLift2024-02-26
07290110123475 - Alma SupErb2024-02-26
07290110123482 - ClearSkin2024-02-26
07290110123444 - NIR Face (6) HP2024-02-07

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