Alma Beauty Remove System 100-120V AASP05101401WA0001

GUDID 17290110121294

ALMA LASERS LTD.

Multi-modality skin surface treatment system
Primary Device ID17290110121294
NIH Device Record Key6d04e309-58b2-4acb-9618-1ba6e51c67b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlma Beauty Remove System 100-120V
Version Model Number1
Catalog NumberAASP05101401WA0001
Company DUNS532283264
Company NameALMA LASERS LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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
GS117290110121294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by ALMA LASERS LTD.

07290110123567 - Alma TED System 120V 50/60HZ2024-09-23 Alma TED System 120V 50/60HZ
07290110123611 - TED Applicator2024-09-23 TED Applicator
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.