FDA.reportPublic FDA data

BLU-U® Blue Light Photodynamic Therapy Illuminator

Primary DI
M706417011
Brand
BLU-U® Blue Light Photodynamic Therapy Illuminator
Company
DUSA PHARMACEUTICALS INC.
Model
4170-1
Catalog number
4170-1
Device description
The 4170-1 is the Head Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3).The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
Published
2014-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
P990019001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990019001BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATORSun Pharmaceutical Industries, Inc.1999-12-03MVF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M706417011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Skin photodynamic therapy/phototherapy lampA portable, mains electricity (AC-powered) lamp intended to emit low-level narrow-band (LLNB) red light (e.g., 600-650nm) and blue light (e.g., 415-440nm) either separately or simultaneously for photodynamic therapy (PDT) applications (with photosensitizing agent) to treat skin disorders such as actinic keratosis and non-melanoma skin cancer, and for phototherapy applications (through modification of skin metabolism) to treat skin complaints such as acne, rosacea and sun spots. It uses light-emitting diodes (LEDs) to produce a heatless light source which may be used for treatment at multiple anatomical sites. It is intended to be used by a healthcare professional in a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
877-533-3872customerservice@dusapharma.com

Regulatory Flags#

DUNS number
109234786
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
M706417021BLU-U® Blue Light Photodynamic Therapy Illuminator4170-24170-22014-09-15
M706417031BLU-U® Blue Light Photodynamic Therapy Illuminator4170-34170-32014-09-15

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
00376128000179Photofrin® 630 PDT LaserPinnacle Biologics, Inc.MVF2018-02-13
00376128000155Photofrin® 630 PDT LaserPinnacle Biologics, Inc.MVF2016-09-19
M706417021BLU-U® Blue Light Photodynamic Therapy IlluminatorDUSA PHARMACEUTICALS INC.MVF2014-09-15
M706417031BLU-U® Blue Light Photodynamic Therapy IlluminatorDUSA PHARMACEUTICALS INC.MVF2014-09-15