FDA.reportPublic FDA data

LightStim & HydraFacial Elipsa

Primary DI
00850030819024
Brand
LightStim & HydraFacial Elipsa
Company
LED INTELLECTUAL PROPERTIES LLC
Model
Elipsa Black
Catalog number
1614-01
Device description
Light Therapy Device
Published
2022-03-07
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
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030819024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030819024008500308190248500308190240850030819024

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-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, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963347211
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030819086LightStim Recovery LoopOne Pod20132025-08-13
00850030819093LightStim Recovery LoopTwo Pods20142025-08-13
00850030819031LightStim for Acne / LightStim+ AcneLS4A / ALS-Pro2022-06-27
00850030819048LightStim for Wrinkles / LightStim+ Anti AgingLS4W / AALS-Pro2022-06-27
00850030819055LightStim+ ProPanel for Pain / Anti-AgingPP-PLS / PP-AALS2022-06-27
00850030819062LightStim for PainLS4P2022-06-27
00850030819079LightStim+ ProPanel for AcnePP-ALS2022-06-27
00850030819017LightStim LED BEDLSBED-P-182401-11352021-06-16

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