Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY ON CABAS E 411

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI -HCV IMMUNOASSAY ON COBAS E 601

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV INMMUNOASSAY ON COBAS E 411

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170

LED Eye mask (EY-20R, A20, EY-20N)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)

FDA 510(k)

FDA Class 2 ·Physical Medicine

HIGHERDOSE Red and Infrared Light Mask (MK66-L)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bioceramic Root Repair Material (C-Root BP)

FDA 510(k)

FDA Class 2 ·Dental

Home Use Hair Removal Device/T1, T2, T3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electrical Stimulator System

FDA 510(k)

FDA Class 2 ·Neurology

Nooance Led And Laser Helmet

FDA 510(k)

FDA Class 2 ·Physical Medicine

Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Solawave 2-in-1 Skincare Mini (Model: 61043)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Blood Pressure Monitor(Model:Y30001)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Suction Irrigation Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electrical Stimulator System

FDA 510(k)

FDA Class 2 ·Neurology

Aneroid Sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EnergyLounger (TY-01)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery