Device Classification Name powered laser surgical instrument
510(k) Number K170734
Device Name Venus Silk.expert
Applicant
Cyden Limited
Technium 2, Kings Road, The Docks
swansea,  GB sa1 8pj
Applicant Contact mike kiernan
Correspondent
Cyden Limited
Technium 2, Kings Road, The Docks
swansea,  GB sa1 8pj
Correspondent Contact mike kiernan
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
OHT  
Date Received03/10/2017
Decision Date 05/08/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
statement statement
Type Special
Reviewed by Third Party No
Combination Product No