FOTONA XP ND: YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA NOVALIS ER: YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dynamis Pro Family

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA DUALIS PLUS ND:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MESI mTablet ECG Diagnostic System, MESI mTablet ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

FOTONA NOVALIS R RUBY LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tosama Biobased Applicator Tube Menstrual Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Automated ankle brachial pressure index measuring device, MESI mTABLET system

FDA 510(k)

FDA Class 2 ·Cardiovascular

StarWalker

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA QX ND:YAG/KTP LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fotona XPulse Pro Laser Platform

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LightWalker Laser System Family

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PMMA CAD/CAM DISC

FDA 510(k)

FDA Class 2 ·Dental

FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tosama 100% Cotton Menstrual Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DATAMEDIX PECGASYS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular