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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K103501

ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES · Alma Lasers, Inc. · decided 2011-01-14 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Pixel CO2 Hand Piece 9x9 & 7x7 alma1ALMA LASERS LTD.HQF17290110120778
Handpiece Focus 100mm for CO2 Alma1ALMA LASERS LTD.HQF17290110120747
FemiLift Slim Sleeve 61ALMA LASERS LTD.GEX HQF17290110122031
Handpiece Focus 50mm for CO2 Alma1ALMA LASERS LTD.HQF17290110120761
FemiLift Sleeve1ALMA LASERS LTD.GEX HQF17290110121959
FemiLift Smart Protector 61ALMA LASERS LTD.GEX HQF17290110122055
Femilift HP & Camera1ALMA LASERS LTD.HQF17290110120792
FemiLift Smart Protector1ALMA LASERS LTD.GEX HQF17290110122000
FemiLift Slim Sleeve 11ALMA LASERS LTD.GEX HQF17290110122024
FemiLift Hygienic, Single Use Probe Set (6 units)1ALMA LASERS LTD.GEX17290110121737
iPixel Module - Line Scan With Wheel and Support1ALMA LASERS LTD.HQF17290110120815
CO2 LiteScan Applicator FOR INC1ALMA LASERS LTD.GEX07290110123888
Handpiece Focus 200mm Surgical for CO2 Alma1ALMA LASERS LTD.HQF17290110120754
FemiLift Slim Sleeve 241ALMA LASERS LTD.GEX HQF17290110122048
FemiLift Smart Protector Tyvac1ALMA LASERS LTD.GEX HQF17290110121997
CO2 Lite Scan (rev.2)1ALMA LASERS LTD.HQF17290110120730
FemiLift Sleeve1ALMA LASERS LTD.GEX HQF17290110121980
FemiLift Sleeve1ALMA LASERS LTD.GEX HQF17290110121973
FemiLift Slim Sleeve1ALMA LASERS LTD.GEX HQF17290110122017
CO2 Scanner system 100-120V 30W (Modem)1ALMA LASERS LTD.HQF17290110120969
FemiLift Sleeve1ALMA LASERS LTD.GEX HQF17290110121966
FemiLift Hygienic, Single Use Probe1ALMA LASERS LTD.GEX17290110121744