FDA.reportPublic FDA data

A.C.E Blue

Primary DI
00864918000305
Brand
A.C.E Blue
Company
PULSADERM LLC
Model
PD9505
Device description
Blue Light for the treatment of 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
00864918000305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864918000305008649180003058649180003050864918000305

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
00864918000312Pulsaderm RED LED Skin RenewalPD5000R2018-10-04
00864918000329 Blue LED Acne Clearing LightPD5000B2018-10-04
00864918000336A.C.E Red and Blue PD9500 2018-10-04

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