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

Clearance record K143554

Venus Legacy CX · Venus Concept , Ltd. · decided 2015-08-04 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Venus Legacy kitPK000002VENUS CONCEPT LTDGEI PBX07290016540116
Venus Legacy (100V)LE100004Venus Concept Inc.PBX00810060830826
Venus Legacy (240V) LE240004Venus Concept Inc.PBX00810060830840
LB2 applicatorAS100005VENUS CONCEPT LTDGEI PBX07290016540017
Venus Legacy (120V)LE120004Venus Concept Inc.PBX00810060830833
Venus LegacyLE120004VENUS CONCEPT LTDGEI PBX07290016540000
LB1 + LF1 kitPK000041VENUS CONCEPT LTDGEI PBX07290016540079
Venus Legacy - 110V SystemLE100004VENUS CONCEPT LTDGEI PBX07290016540086
Venus LegacyLE240004VENUS CONCEPT LTDGEI PBX07290016540109
LB2 + LF2 kitPK000039VENUS CONCEPT LTDGEI PBX07290016540062
LB1 applicatorAS100006VENUS CONCEPT LTDGEI PBX07290016540024
Venus Legacy kitPK000008VENUS CONCEPT LTDGEI PBX07290016540055
LF1 applicatorAS100007VENUS CONCEPT LTDGEI PBX07290016540031
Venus Legacy 110V - NikaoLE120004NIVENUS CONCEPT LTDGEI PBX07290016541533
Venus Legacy CX - LF2 applicator (new design)AS100075VENUS CONCEPT LTDGEI PBX07290016540963
Venus Legacy 240V - NikaoAS100005NIVENUS CONCEPT LTDGEI PBX07290016541472
Venus Legacy CX - LB2 applicator (new design)AS100063VENUS CONCEPT LTDGEI PBX07290016540765
LF2 applicatorAS100008VENUS CONCEPT LTDGEI PBX07290016540048