LAS-R TM HUMAN COMPLEMENT C4 TEST

FDA 510(k)

FDA Class 2 ·Immunology

LAS-R HUMAN C1 ESTERASE INHIBITOR TEST

FDA 510(k)

FDA Class 2 ·Immunology

CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPECTRA HAIR REMOVAL LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADEPT ULTRALITE 532 LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPECTRAGENICS ATS-1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring

FDA 510(k)

FDA Class 2 ·Dental

COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

InkSpace Imaging Small Body Array

FDA 510(k)

FDA Class 2 ·Radiology

RETCAM 3 OPHTHALMIC IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

TRIA HAIR REMOVAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADEPT 1064/532/755 LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring

FDA 510(k)

FDA Class 2 ·Dental

RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP

FDA 510(k)

FDA Class 2 ·Ophthalmic

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS

FDA 510(k)

FDA Class 2 ·Ophthalmic

InkSpace Imaging Pediatric Body Array

FDA 510(k)

FDA Class 2 ·Radiology