System, Laser, Fiber Optic, Photodynamic Therapy

Product Code: MVG

Medical Laser 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: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations:


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as MVG

5943System, Laser, Fiber Optic, Photodynamic Therapy

Total Product Life Cycle (TPLC) Devices

5943System, Laser, Fiber Optic, Photodynamic Therapy

FDA Consensus Standards

System, Laser, Fiber Optic, Photodynamic Therapy [32410]21 CFR Unclassified 🔎
System, Laser, Fiber Optic, Photodynamic Therapy [32150]21 CFR Unclassified 🔎

Pre-market Approvals for MVG

P940010OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)CONCORDIA LABORATORIES, INC

Global Unique Device Identification Database

00376128000148System, Laser, Fiber Optic, Photodynamic Therapy
00376128000131System, Laser, Fiber Optic, Photodynamic Therapy
00376128000124System, Laser, Fiber Optic, Photodynamic Therapy
00376128000117System, Laser, Fiber Optic, Photodynamic Therapy
00376128000100System, Laser, Fiber Optic, Photodynamic Therapy
00376128000094System, Laser, Fiber Optic, Photodynamic Therapy
00376128000087System, Laser, Fiber Optic, Photodynamic Therapy
00376128000070System, Laser, Fiber Optic, Photodynamic Therapy
00376128000063System, Laser, Fiber Optic, Photodynamic Therapy
00376128000056System, Laser, Fiber Optic, Photodynamic Therapy
00376128000049System, Laser, Fiber Optic, Photodynamic Therapy
00376128000032System, Laser, Fiber Optic, Photodynamic Therapy
00376128000025System, Laser, Fiber Optic, Photodynamic Therapy
00376128000018System, Laser, Fiber Optic, Photodynamic Therapy
00376128000346System, Laser, Fiber Optic, Photodynamic Therapy

Maude Adverse Events

OPTIGUIDE FIBER OPTIC DIFFUSERPINNACLE BIOLOGICS, INC.2020-02-28
OPTIGUIDE? DCYL CYLINDRICAL DIFFUSERPINNACLE BIOLOGICS, INC.2020-02-10
OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIESPINNACLE BIOLOGICS, INC.2019-08-06
OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIESPINNACLE BIOLOGICS, INC.2019-07-09
FIBER, LASER, SHEATHKARL STORZ ENDOSCOPY-AMERICA, INC.2016-11-16
OPTIGUIDEDIOMED, INC.2004-11-03
DCYL 250DIOMED AXCAN2004-09-21

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