Photofrin® 630 PDT Laser

Primary DI
00376128000179
Brand
Photofrin® 630 PDT Laser
Company
Pinnacle Biologics, Inc.
Model
63012
Device description
630nm Photodynamic Therapy Laser
Published
2018-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVFSystem, Laser, Photodynamic Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVFSystem, Laser, Photodynamic TherapyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990021003
P990021004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990021003DIOMED 630 PDT LASERPinnacle Biologics, Inc.2000-06-30MVF
P990021004DIOMED 630 PDT LASERPinnacle Biologics, Inc.2000-06-30MVF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00376128000179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00376128000179003761280001793761280001790376128000179

GMDN Terms#

Term, Definition table
TermDefinition
Oncological diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power [i.e., not considered low-level laser therapy (LLLT)], therapeutic laser beam, typically of visible red-light, intended for oncological photodynamic therapy (PDT) and photochemical internalization (PCI). It is part of a drug-device therapy that combines a pharmaceutical photosensitizer with photoactivation for local cancer treatment. The software-controlled device is designed to deliver cylindrical diffusing outputs and/or frontal diffusing output for surface treatment and/or for interstitial treatment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
773-312-3723info@pinnaclebiologics.com
1-866-248-2039productinfo@concordialaboratories.com

Regulatory Flags#

DUNS number
833037612
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00376128000193Photofrin® 630 PDT Laser BWF5-630-2-PIN2022-03-11
00376128000223Optiguide® Cylindrical Fiber Optic Diffuser2102019-08-30
00376128000230Optiguide® Cylindrical Fiber Optic Diffuser2152019-08-30
00376128000247Optiguide® Cylindrical Fiber Optic Diffuser2202019-08-30
00376128000254Optiguide® Cylindrical Fiber Optic Diffuser2252019-08-30
00376128000261Optiguide® Cylindrical Fiber Optic Diffuser2502019-08-30
00376128000278Optiguide® Cylindrical Fiber Optic Diffuser2302019-08-30
00376128000353OPTIGUIDE® Cylindrical Diffuser7152019-11-07
00376128000360OPTIGUIDE® Cylindrical Diffuser7202019-11-07
00376128000377OPTIGUIDE® Cylindrical Diffuser7252019-11-07
00376128000384OPTIGUIDE® Cylindrical Diffuser7302019-11-07
00376128000391OPTIGUIDE® Cylindrical Diffuser7502019-11-07
00376128000346OPTIGUIDE® Cylindrical Diffuser7102019-11-06
00376128000018OPTIGUIDE® DCYL Cylindrical Diffuser7102014-09-16
00376128000025OPTIGUIDE® DCYL Cylindrical Diffuser7202014-09-16
00376128000032OPTIGUIDE® DCYL Cylindrical Diffuser7152014-09-16
00376128000049OPTIGUIDE® DCYL Cylindrical Diffuser7302014-09-16
00376128000056OPTIGUIDE® DCYL Cylindrical Diffuser7252014-09-16
00376128000063OPTIGUIDE® DCYL Cylindrical Diffuser7402014-09-16
00376128000070OPTIGUIDE® DCYL Cylindrical Diffuser7502014-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06429810677020Modulight ML6710i Laser and ML-SLAModulight OyjMVF2023-08-01
00376128000193Photofrin® 630 PDT Laser Pinnacle Biologics, Inc.MVF2022-03-11
00376128000155Photofrin® 630 PDT LaserPinnacle Biologics, Inc.MVF2016-09-19
M706417011BLU-U® Blue Light Photodynamic Therapy IlluminatorDUSA PHARMACEUTICALS INC.MVF2014-09-15
M706417021BLU-U® Blue Light Photodynamic Therapy IlluminatorDUSA PHARMACEUTICALS INC.MVF2014-09-15
M706417031BLU-U® Blue Light Photodynamic Therapy IlluminatorDUSA PHARMACEUTICALS INC.MVF2014-09-15