FDA.reportPublic FDA data

Celluma

Primary DI
00850075326006
Brand
Celluma
Company
Biophotas, Inc.
Model
Series 2 CONTOUR PLUS
Catalog number
CT5M-001
Device description
3 Panel 5 Mode Low Level Light Therapy Device
Published
2025-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152280000
K171323000
K211038000
K232977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152280000BioPhotas Celluma3Biophotas, Inc.2016-03-02ILY
K171323000BIOPHOTAS CELLUMA3Biophotas, Inc.2017-09-01OHS
K211038000Biophotas Celluma RESTOREBiophotas, Inc.2021-06-29OAP
K232977000Biophotas Celluma CONTOURBiophotas, Inc.2023-11-21OLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850075326006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075326006008500753260068500753260060850075326006

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
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850523007365CellumaMYSTIQUECFM-0012026-04-06
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
00850523007143CellumaDELUX XL C/USCDLX-0032020-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850001456814Velora REDOmm Imports Inc.OHS2026-07-26
00810140062833RENPHOJoicom CorporationILY2026-07-24
00810140063113RENPHOJoicom CorporationILY2026-07-24
00810140063120RENPHOJoicom CorporationILY2026-07-24
00850083596002LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850083596026LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850026680218Aura WellnessAura Wellness, LLCILY2026-07-21
00858985006391Erchonia CLXERCHONIA CORPORATION, LLCOLI2026-07-21
08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
06974958310587ideatherapyShenzhen Idea Light LimitedOAP2026-07-09
06977638360483Hair Growth DeviceDongguan Boyuan Intelligent Technology Co.,LtdOAP2026-07-09
06977638360612Hair Growth DeviceDongguan Boyuan Intelligent Technology Co.,LtdOAP2026-07-09
00860015912503BOB AND BRADAmazing Impulse, LLCOHS2026-07-06
00731093153129CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
00850079561014CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
00860011935582CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
00860011935599CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
06970006973285CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
00810140063090RenphoJoicom CorporationOHS2026-06-23
05061091983134Beauty PieLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDOAP2026-06-23
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02