FDA.reportPublic FDA data

Celluma

Primary DI
00850523007761
Brand
Celluma
Company
Biophotas, Inc.
Model
Series 2 ELITE C/US
Catalog number
ELS2-002
Device description
5 Mode Light therapy device with capability of 3 Panels connected
Published
2024-12-23
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
OAPLaser, Comb, Hair
OHSLight Based Over The Counter Wrinkle Reduction
OLIFat Reducing Low Level Laser
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
OAPLaser, Comb, HairPhysical Medicine2
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLIFat Reducing Low Level LaserGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850523007761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850523007761008505230077618505230077610850523007761

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
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
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
00850523007143CellumaDELUX XL C/USCDLX-0032020-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855264008695CamarAura MedicalOHS2026-10-22
00855264008695CamarAura MedicalOLP2026-10-22
06975981280045RedfySunPlus LED Technology Co., Ltd.ILY2026-10-21
06975981280052RedfySunPlus LED Technology Co., Ltd.ILY2026-10-21
06975981280076RedfySunPlus LED Technology Co., Ltd.ILY2026-10-21
06975981280144RedfySunPlus LED Technology Co., Ltd.ILY2026-10-21
00622356757744Shark™ CryoGlowSharkNinja Operating LLCOLP2026-10-19
00622356757744Shark™ CryoGlowSharkNinja Operating LLCOHS2026-10-19
00810045461632CapillusCAPILLUS, LLCOHS2026-10-19
00810045461632CapillusCAPILLUS, LLCOLP2026-10-19
00850079561632CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-10-16
00850079561649CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-10-16
07090072490000FlexBeamRecharge Health ASILY2026-10-15
04897111807354Project E BeautyDUPLEX INTERNATIONAL TRADING LIMITEDOLP2026-10-01
04897111807354Project E BeautyDUPLEX INTERNATIONAL TRADING LIMITEDOHS2026-10-01
00850012528630ILYEO bodyJoylux, Inc.ILY2026-09-29
00850061407221LS Pro SystemsWELLNESS WITHOUT LIMITS LLCILY2026-09-24
06974958310594mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310600mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310617mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310624mitoredlightShenzhen Idea Light LimitedILY2026-09-21
10622356707562Shark™ CryoGlowSharkNinja Operating LLCOHS2026-09-21
10622356707562Shark™ CryoGlowSharkNinja Operating LLCOLP2026-09-21
06953808301241Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-10
06953808301265Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-10
06953808301692Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-01
06953808301739Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-01
06953808301746Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-01
06953808301777Laser Therapy Hair Growth CombHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-01
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27