FDA.reportPublic FDA data

Blue LED Acne Clearing Light

Primary DI
00864918000329
Brand
Blue LED Acne Clearing Light
Company
PULSADERM LLC
Model
PD5000B
Device description
Blue LED Light for the treatment of mild to moderate acne
Published
2018-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864918000329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864918000329008649180003298649180003290864918000329

GMDN Terms#

Term, Definition table
TermDefinition
Red/blue light phototherapy unitA portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080429881
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858830007023Instant Face Lift RB200002018-10-04
00858830007764PulsadermPD9700R2020-08-07
00858830007061Orbital LED Mask RB20152018-10-04
00858830007191Hair Laser HelmetRB20402018-10-04
00864918000343NutraStim Hair Laser CombPD8021NS2018-10-03
00864918000374L.E.D Light Therapy Mask (Red) RB20102018-10-04
00858830007047LED Blue Acne Clearing Mask PD97002018-10-04
00864918000305A.C.E Blue PD95052018-10-04
00864918000312Pulsaderm RED LED Skin RenewalPD5000R2018-10-04
00864918000336A.C.E Red and Blue PD9500 2018-10-04

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