Visual-ICE Cryoablation System, Software Revision 1.3.1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CryoDose H or Similar

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Claritag Advanced

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IcePearl 2.1 CX L, IceForce 2.1 CX L

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANDELA CRYOSYSTEM CS-5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRYO-HIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRYOPEN CRYOSURGICAL SYSTEM, K102214

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRYOCARE SURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRYOMEGA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ClariFix

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CCS100 CRYOSURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

truFreeze System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

cryoICE croablation probe

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CMS CRYOLITE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VISUAL-ICE CRYOABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CMS ACCUPROBE 550/530

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery