FDA.reportPublic FDA data

Celluma

Primary DI
00850523007600
Brand
Celluma
Company
Biophotas, Inc.
Model
SKIN C/US
Catalog number
CSKN-001
Device description
2-mode large panel
Published
2020-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171323000BIOPHOTAS CELLUMA3Biophotas, Inc.2017-09-01OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850523007600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850523007600008505230076008505230076000850523007600

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
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
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06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
00860016300309LMNTXPLR LTDOLP2026-08-17
00860016300309LMNTXPLR LTDOHS2026-08-17
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
09361725025404BON CHARGELight Tree Ventures Europe B.V.OHS2026-08-11
09361725025411BON CHARGELight Tree Ventures Europe B.V.OHS2026-08-11
05060534511521ELEMIS Red Light MaskI-SMART DEVELOPMENTS LIMITEDOHS2026-08-07
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OHS2026-07-30
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OLP2026-07-30
00850001456814Velora REDOmm Imports Inc.OHS2026-07-26
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16