FDA.reportPublic FDA data

Celluma

Primary DI
00850523007204
Brand
Celluma
Company
Biophotas, Inc.
Model
Lite C/US
Published
2016-09-22
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
ILYLamp, Infrared, Therapeutic Heating
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
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
00850523007204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850523007204008505230072048505230072040850523007204

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
063400364
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850523007365CellumaMYSTIQUECFM-0012026-04-06
00850075326006CellumaSeries 2 CONTOUR PLUSCT5M-0012025-07-24
00850075326044CellumaSeries 2 NOVA C/USCNV2-0012025-07-24
00850523007594CellumaSeries 2 CONTOUR C/USCTG2-0012024-12-23
00850523007754CellumaSeries 2 FACE C/USCLF2-0012024-12-23
00850523007761CellumaSeries 2 ELITE C/USELS2-0022024-12-23
00850523007808CellumaSeries 2 SKIN C/USCSK2-0012024-12-23
00850523007891CellumaSeries 2 DELUX C/USCDL2-0012024-12-23
00850523007938CellumaSeries 2 DELUX XL C/USCXL2-0012024-12-23
00850523007648CellumaSeries 2 SPORT C/USCSP2-0012024-12-20
00850523007709CellumaSeries 2 PRO PLUS C/USCPM2-0012024-12-20
00850523007716CellumaSeries 2 PRO C/USCLP2-0012024-12-20
00850523007723CellumaSeries 2 LITE C/USCML2-0012024-12-20
00850523007730CellumaSeries 2 RESTORE C/USCLR2-0012024-12-20
00850523007747CellumaSeries 2 HOME C/USCPM2-0012024-12-20
00850523007136CellumaRESTORE C/USCLRS-0012021-10-11
00850523007037CellumaCLEAR C/USCLTC-0012020-06-11
00850523007051CellumaFACE C/USCLTF-0012020-06-11
00850523007075CellumaSPORT C/USCSPT-0012020-06-11
00850523007129CellumaDELUX C/USCDLX-0012020-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OHS2026-05-28
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOLP2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCILY2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23