System, Laser, Photodynamic Therapy

Product Code: MVF

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 MVF

5942System, Laser, Photodynamic Therapy

Total Product Life Cycle (TPLC) Devices

5942System, Laser, Photodynamic Therapy

FDA Consensus Standards

System, Laser, Photodynamic Therapy [32410]21 CFR Unclassified 🔎
System, Laser, Photodynamic Therapy [32150]21 CFR Unclassified 🔎
System, Laser, Photodynamic Therapy [29958]21 CFR Unclassified 🔎

Pre-market Approvals for MVF

P990048ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTERCARL ZEISS MEDITEC AG
P990049COHERENT OPAL PHOTOACTIVATOR LASER SYSTEMLUMENIS
P990019BLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATORDUSA PHARMACEUTICALS, INC.
P990021PHOTOFRIN 630 PDT LaserCONCORDIA LABORATORIES, INC

Global Unique Device Identification Database

00376128000179System, Laser, Photodynamic Therapy
00376128000155System, Laser, Photodynamic Therapy
00376128000193System, Laser, Photodynamic Therapy
06429810677020System, Laser, Photodynamic Therapy

Maude Adverse Events

BLU-U (BLUE LIGHT PHOTODYNAMIC THERAPY III)DUSA PHARMACEUTICALS, INC.2020-02-05
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATORDUSA PHARMACEUTICALS, INC.2019-10-01
BLU-U LIGHTSUN DERMATOLOGY PHARMACEUTICALS / DUSA PHARMACEUTICALS, INC.2019-09-10
BLU-USUN DERMATOLOGY / DUSA PHARMACEUTICALS, INC.2019-06-21
BLUE LIGHT-PHOTODYNAMIC THERAPY ILLUMINATOR MODEL 4170DUSA PHARMACEUTICALS, INC.2019-05-09
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC.2018-06-27
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC.2018-06-13
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC.2018-05-02
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC.2018-04-25
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC.2018-04-04
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC.2018-03-28
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC.2018-03-23
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC.2018-03-23
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC.2018-03-15
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC, A SUN PHARMA COMPANY2018-03-09
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC, A SUN PHARMA COMPANY2018-03-09
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC, A SUN PHARMA COMPANY2018-03-01
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORDUSA PHARMACEUTICALS, LNC.2018-03-01
BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR (LEVULAN KERASTICK AND BLU-U PDT)DUSA PHARMACEUTICALS2018-01-08
PDTSYSTEM, LASER, PHOTODYNAMIC THERAPYDUSA2017-10-24
PHOTODYNAMIC THERAPYDUSA PHARMACEUTICALS, INC.2017-07-24
PHOTOFRIN 630 PDT LASERPINNACLE BIOLOGICS INC2017-01-18
PHOTOFRIN 630 PDT LASERPINNACLE BIOLOGICS INC.2017-01-06
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATORDUSA PHARMACEUTICALS, INC.2015-10-08
BLUE LIGHT DERMATOLOGY TREATMENT2015-07-17
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATORDUSA PHARMACEUTICALS, INC.2014-05-09
LIGHT, ULTRAVIOLET, DERMATOLOGICALDUSA PHARMACEUTICALS2014-04-28
BLU-U LIGHT TREATMENTDUSA PHARMACEUTICALS2014-03-19
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOREDUSA PHARMACEUTICALS, INC.2013-11-12
LEVULAN KERASTICK WITH BLU-UDUSA PHAMACEUTICALS, INC.2013-04-04
QUANTEL2012-11-10
QUANTUMLUMENIS, INC.2007-01-05
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPYDUSA PHARMACEUTICALS, INC.2006-01-19
CRITERION PDT LASERCRITERION2005-11-21
LUMENIS SLIMLINE 200 FOR COHERENT 200LUMENIS, INC.2005-07-18
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATORDUSA PHARMACEUTICALS, INC.2005-07-06
BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATORDUSA PHARMACEUTICALS, INC.2004-07-22
BLU-U PHOTODYNAMIC ILLUMINATORDUSA PHARMACEUTICALS, INC.2002-03-06

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