Handpiece Cooled 540 (3) for Harmony XL 50000 puls AAHP01050802

GUDID 17290110120266

ALMA LASERS LTD.

Multi-modality skin surface treatment system Multi-modality skin surface treatment system
Primary Device ID17290110120266
NIH Device Record Key5f684c92-d262-4c2e-8866-f1c697967af9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandpiece Cooled 540 (3) for Harmony XL 50000 puls
Version Model Number1
Catalog NumberAAHP01050802
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
GS117290110120266 [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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