Headlight, Fiberoptic Focusing

Product Code: FCT

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: 886.4335


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as FCT

4134Headlight, Fiberoptic FocusingOperating Headlamp.

Total Product Life Cycle (TPLC) Devices

4134Headlight, Fiberoptic FocusingOperating Headlamp.

Pre-market Notifications for FCT

K960767LIGHT COMMANDERSCIERAN TECHNOLOGIES, INC.
K924198MODIFIED SITE FIBER OPTIC MODULECHIRON VISION CORP.
K883480MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USESITE MICROSURGICAL SYSTEMS, INC.
K802769FIBER OPTIC HEADLIGHT #60-0765ASPEN LABORATORIES, INC.
K802770FIBER OPTIC HEADLIGHT #60-0766766ASPEN LABORATORIES, INC.
K780433FIBER OPTIC ADJUSTABLE HEADLIGHTCAMERON-MILLER, INC.

Global Unique Device Identification Database

00851321006116Headlight, fiberoptic focusing
00841645132028Headlight, Fiberoptic Focusing
00841645132011Headlight, Fiberoptic Focusing
00841645132004Headlight, Fiberoptic Focusing
04055207008751Headlight, fiberoptic focusing
00862658000326Headlight, Fiberoptic Focusing
B366HDL200Headlight, Fiberoptic Focusing
M678HLM0Headlight, Fiberoptic Focusing
M678HL0Headlight, Fiberoptic Focusing
01816835024062Headlight, Fiberoptic Focusing
01816835024055Headlight, Fiberoptic Focusing
01816835024031Headlight, Fiberoptic Focusing
01816835024024Headlight, Fiberoptic Focusing
01816835024017Headlight, Fiberoptic Focusing
01816835023997Headlight, Fiberoptic Focusing

Maude Adverse Events

LIGHT PIPEALCON LABORATORIES,INC.2006-01-12
FOCUSNATIONAL MEDICAL CARE1994-03-07
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