Transilluminator, Ac-powered

Product Code: HJM

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 HJM

4152Transilluminator, Ac-poweredTransilluminator.

Total Product Life Cycle (TPLC) Devices

4152Transilluminator, Ac-poweredTransilluminator.

Pre-market Notifications for HJM

K972506INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATORINFINITECH, INC.
K950529PEREGRINE DIFFUSION LIGHT PIPEPEREGRINE SURGICAL LTD.
K945877WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHTWELLS JOHNSON CO.
K940393PEREGRINE WIDE ANGLE LIGHT PIPEPEREGRINE SURGICAL LTD.
K934269FIBEROPTIC ILLUMINATED INSTRUMENTSVISITEC CO.
K933445DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)STORZ INSTRUMENT CO.
K931072HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBEHGM, INC.
K913273DROLITE(TM) LIGHT SOURCEVISION MEDICAL, INC.
K894513DIATHRON(R) DIATHERMY UNITINTL. OPHTHALMIC INDUSTRIES CORP.
K893170VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)KEELER INSTRUMENTS, INC.
K812949RMI TRANSILLUMINATOR, MODEL 292RADIATION MEASUREMENTS, INC.
K811108RMI TRANSILLUMINATION LIGHT METER #295RADIATION MEASUREMENTS, INC.

Global Unique Device Identification Database

10632307001298Transilluminator, ac-powered
10632307001250Transilluminator, ac-powered
10632307001199Transilluminator, ac-powered
10632307001137Transilluminator, ac-powered
10632307001014Transilluminator, ac-powered
17290109140763Transilluminator, Ac-Powered
17290109140756Transilluminator, Ac-Powered
05055272715140Transilluminator, Ac-Powered
05055272707794Transilluminator, Ac-Powered
B396MSK1116050Transilluminator, Ac-Powered
B3960501120Transilluminator, Ac-Powered
B3960501020Transilluminator, Ac-Powered
B396050100VT0Transilluminator, Ac-Powered
B396050080VT0Transilluminator, Ac-Powered
20841305110216Transilluminator, ac-powered

Maude Adverse Events

VENOSCOPE IIVENOSCOPE2016-11-02
VENOSCOPE IIVENOSCOPE2016-11-02
*TRANSILLUMINATOR, AC-POWEREDOHMEDA MEDICAL2015-06-30
LUMITEX MD LIGHTMAT SURGICAL ILLUMINATORLUMITEX MD, INC2015-03-16
LIGHTMATLUMITEX2013-06-26
*LIGHT SOURCECHIU TECHNICAL CORP2007-04-12
ENDO ILLUMINATORINFINITECH, INC.1996-11-15
DUAL LIGHT SOURCE TRANS-ILLUMINATORSYLVAN CORPORATION1992-07-09
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