Handpiece ER iPixel 4Hz Er:YAG 2940 High Power Harmony XL / Pro AAHP08031503WR0002

GUDID 17290110121942

ALMA LASERS LTD.

Multi-modality skin surface treatment system
Primary Device ID17290110121942
NIH Device Record Key2f528dfe-c08c-4c49-9066-2ca581c2c1f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandpiece ER iPixel 4Hz Er:YAG 2940 High Power Harmony XL / Pro
Version Model Number02
Catalog NumberAAHP08031503WR0002
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290110121942 [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 Date2020-07-02
Device Publish Date2020-06-24

Devices Manufactured by ALMA LASERS LTD.

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
07290110123406 - Iris SR IPL HP2024-02-06
07290110123413 - Iris VL/PL IPL HP2024-02-06

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