Transilluminator, Battery-powered

Product Code: HJN

Ophthalmic General Optical Products / Medical

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: 886.1945


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as HJN

4153Transilluminator, Battery-poweredTransilluminator.

Total Product Life Cycle (TPLC) Devices

4153Transilluminator, Battery-poweredTransilluminator.

Pre-market Notifications for HJN

K941035VENOSCOPETRINITY PARTNERS, LLC.
K912747LULMITEX NEONATAL TRANSILLUMINATORLUMITEX, INC.
K901309SYLVAN PEDIASCAN 200 TRANSILLUMINATORSYLVAN CORP.

Global Unique Device Identification Database

00723896009079Transilluminator, Battery-Powered
00723896009048Transilluminator, Battery-Powered
00812594012686Transilluminator, Battery-Powered
00812594012679Transilluminator, Battery-Powered
00812594012662Transilluminator, Battery-Powered
00812594012655Transilluminator, Battery-Powered
00812594012648Transilluminator, Battery-Powered
00812594012624Transilluminator, Battery-Powered
00812594012617Transilluminator, Battery-Powered
00812594012594Transilluminator, Battery-Powered
00732094175165Transilluminator, battery-powered
B853VT030Transilluminator, Battery-Powered
B853NT010Transilluminator, Battery-Powered
00860003720509Transilluminator, Battery-Powered
00812594013089Transilluminator, Battery-Powered

Maude Adverse Events

WEE SIGHTPHILIPS MEDICAL SYSTEMS2018-10-22
VENOSCOPE2016-12-07
LIGHTMAT SURGICAL ILLUMINATORLUMITEX, INC.2015-04-07
ASTODIASTIHLER ELECTRONIC, GMBH2013-03-25
LIGHTMAT SURGICAL ILLUMINATORLUMITEXMD, INC.2012-11-20
LIGHTMATLUMITEX, INC.2010-05-19
LUMITEXMD LIGHT MATLUMITEX2009-12-31
ACMI CORDLUMITEX2009-12-31
LIGHTMAT ULTRA-THIN FLEXIBLE SURGICAL ILLUMINATORLUMITEX2008-07-03
**VENOSCOPE, LLC2006-07-25
VENOSCOPE II NEONATAL TRANSILLUMINATORVENOSCOPE, LLC2005-11-23
VENOSCOPE II NEONATAL TRANSILLUMINATORVENOSCOPE, LLC2005-11-10
VENOSCOPE IIVENOSCOPE2005-05-04
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