Handpiece Harmony/Aria (E) 650 HR AAIP09070709

GUDID 17290110120457

ALMA LASERS LTD.

Multi-modality skin surface treatment system Multi-modality skin surface treatment system
Primary Device ID17290110120457
NIH Device Record Keyfe6d39d6-efaa-4141-b6ac-2119623207d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandpiece Harmony/Aria (E) 650 HR
Version Model Number1
Catalog NumberAAIP09070709
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 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
GS117290110120457 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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