IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )

FDA 510(k)

FDA Class 2 ·Dental

Video Ureteroscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pulse Oximeter ( PO2, PO2A, PO2B)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

FDA 510(k)

FDA Class 2 ·Neurology

3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Self-Fitting hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Lacevo Wearable Breast Pump (Model S70)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Medical electronic thermometer (FC01, FC02)

FDA 510(k)

FDA Class 2 ·General Hospital

Biomic Color Opaque

FDA 510(k)

FDA Class 2 ·Dental

Single-use Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Digital Video Processor

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Single-use Flexible Rhinolaryngoscope; Digital Video Monitor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)

FDA 510(k)

FDA Class 2 ·Neurology

Diode Laser Hair Removal System (SH-VD910)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Keffort (MC-100, MC-100A)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology