Photostimulator, Ac-powered

Product Code: HLX

Ophthalmic Ultraviolet Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 886.1630


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as HLX

4203Photostimulator, Ac-poweredAC-powered Photostimulator.

Total Product Life Cycle (TPLC) Devices

4203Photostimulator, Ac-poweredAC-powered Photostimulator.

Pre-market Notifications for HLX

K003442MODIFICATION TO EDI VERIS SYSTEMELECTRO-DIAGNOSTIC IMAGING, INC.
K983983EDI VERIS SYSTEMELECTRO-DIAGNOSTIC IMAGING, INC.
K925741CLARUS ENDOSCOPIC HOOK KNIFECLARUS MEDICAL SYSTEMS, INC.
K914163SCOPTOPIC SENSITIVITY TEST-1[SST-1]LKC TECHNOLOGIES, INC.
K873990IRAS EDS INTERFEROMETRIC STIMULATORRANDWAL INSTRUMENT CO., INC.
K853812PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)BIOSAN LABORATORIES, INC.
K833446DOWNING SPECTRAL ILLUMINATORVISION HEALTH TECHNOLOGY
K832762MILLER/NADLER GLARE TESTERTITMUS OPTICAL, INC.
K831231LED GOGGLESCADWELL LABORATORIES, INC.
K830770CONTRAST SENSITIVITY EQUIPMENTCADWELL LABORATORIES, INC.
K8229195010 VISUSTIMLIFE-TECH INTL., INC.
K8229225011 GANZFELD STIMULATORLIFE-TECH INTL., INC.
K8229235012 PARABOLIC STIMULATORLIFE-TECH INTL., INC.
K8229155031 BRIGHT FLASH STIMULATORLIFE-TECH INTL., INC.
K812331VTS-1000 VISUAL TESTING SYSTEMNICOLET BIOMEDICAL INSTRUMENTS

Global Unique Device Identification Database

00840067100516Photostimulator, ac-powered

Maude Adverse Events

4.5MM VA LCP INSTRUMENTS AND SCREW SETSYNTHES (USA), LLC2016-03-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.