FDA.reportPublic FDA data

Orbital LED Mask

Primary DI
00858830007061
Brand
Orbital LED Mask
Company
PULSADERM LLC
Model
RB2015
Device description
LED light for the treatment of wrinkles
Published
2018-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858830007061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858830007061008588300070618588300070610858830007061

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable mains electricity (AC-powered) device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness). It is normally available [non-prescription] over-the-counter (OTC) for use by the patient in the home or by a healthcare professional in a clinical setting.

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
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
00864918000329 Blue LED Acne Clearing LightPD5000B2018-10-04
00864918000336A.C.E Red and Blue PD9500 2018-10-04

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