Pixel CO2 7x7 & 9x9 Applicator for Hybrid System AACO28031927

GUDID 17290110122123

Pixel CO2 7x7 & 9x9 Applicator for Hybrid System

ALMA LASERS LTD.

Multi-modality skin surface treatment system
Primary Device ID17290110122123
NIH Device Record Key65de88ac-7af3-4840-b8bd-6a839552db1c
Commercial Distribution Discontinuation2021-07-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePixel CO2 7x7 & 9x9 Applicator for Hybrid System
Version Model Number1
Catalog NumberAACO28031927
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 Usetrue
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
GS117290110122123 [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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