Hybrid System 30W 120V 50/60 HZ AACO15061980BDAZ0004

GUDID 17290110122093

Hybrid System 30W 120V 50/60 HZ

ALMA LASERS LTD.

Multi-modality skin surface treatment system
Primary Device ID17290110122093
NIH Device Record Key13a0df0c-fba2-4e51-b83b-7b9e7ef65291
Commercial Distribution Discontinuation2021-07-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHybrid System 30W 120V 50/60 HZ
Version Model Number1
Catalog NumberAACO15061980BDAZ0004
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290110122093 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-19
Device Publish Date2021-07-11

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