FDA.reportPublic FDA data

COSMEDICO

Primary DI
G619242511
Brand
COSMEDICO
Company
JW NORTH AMERICA, INC.
Model
M 60/80 SE
Catalog number
24251
Device description
Ultraviolet tanning device
Published
2025-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LEJBooth, Sun Tan

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEJBooth, Sun TanGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G619242511PackageHIBCC25In Commercial Distribution
G619242510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet tanning deviceA mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039280558
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G619370140SUPRAQ-0800PIY-L370142026-01-01
G619370141SUPRAQ-0800PIY-L370142026-01-01
G619242500COSMEDICOM 250 SE242502025-12-01
G619242501COSMEDICOM 250 SE242502025-12-01
G619242510COSMEDICOM 60/80 SE242512025-02-01
G619450064090ORIGINAL HANAUOH M 500 SF450064092024-11-01
G619450064110ORIGINAL HANAUOH N 50/100 EF+450064112024-11-01
G619450064890KBLBQ 468 Z4 E450064892024-11-01
G619450065440ORIGINAL HANAUOH N 24/50 EF450065442024-11-01
G619450065490ORIGINAL HANAUOH N 30/50 EF450065492024-11-01
G619450066090KBLBQ 607 Z4 F450066092024-11-01
G619560698990ORIGINAL HANAUOH C 460 SF560698992024-11-01
G619800044570ORIGINAL HANAUOH C 560 SF800044572024-11-01
G619800085990ORIGINAL HANAUOH N 70/120 EF800085992024-11-01
G619800098980ORIGINAL HANAUOH C 400 EF800098982024-11-01
G619800153550ORIGINAL HANAUOH N 800 SF800153552024-11-01
G619800153560ORIGINAL HANAUOH N 800 EF800153562024-11-01
G619800215170ORIGINAL HANAUOH M 60/80 EF800215172024-11-01
G619800231080ORIGINAL HANAUOH M 600 EF800231082024-11-01
G619800261140KBLBQ 460 SF800261142024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5102226NEW TECHNOLOGYLight Sources, Inc.LEJ2026-05-19
G51017010RENUVATANLight Sources, Inc.LEJ2026-05-12
G5101908RENUVATANLight Sources, Inc.LEJ2026-05-12
G5103370RENUVATANLight Sources, Inc.LEJ2026-05-12
G5100821RENUVATANLight Sources, Inc.LEJ2026-05-04
G5100760RENUVATANLight Sources, Inc.LEJ2026-04-29
G5103222RENUVATANLight Sources, Inc.LEJ2026-04-29
G5103137RENUVATANLight Sources, Inc.LEJ2026-04-27
G5103178RENUVATANLight Sources, Inc.LEJ2026-04-22
G1502386VIP PREMIERLight Sources, Inc.LEJ2026-04-20
G1503372GENESISLight Sources, Inc.LEJ2026-04-13
G5101318RENUVATANLight Sources, Inc.LEJ2026-04-10
G5101586RENUVATANLight Sources, Inc.LEJ2026-04-10
G5101915RENUVATANLight Sources, Inc.LEJ2026-04-10
G5102274RENUVATANLight Sources, Inc.LEJ2026-04-10
G5102701RENUVATANLight Sources, Inc.LEJ2026-04-10
G5103119RENUVATANLight Sources, Inc.LEJ2026-04-10
G5103244RENUVATANLight Sources, Inc.LEJ2026-04-10
G5103269RENUVATANLight Sources, Inc.LEJ2026-04-10
G5101180RENUVATANLight Sources, Inc.LEJ2026-04-02
G5101450RENUVATANLight Sources, Inc.LEJ2026-04-02
G5102700RENUVATANLight Sources, Inc.LEJ2026-04-02
G5103133RENUVATANLight Sources, Inc.LEJ2026-04-02
G5103356RENUVATANLight Sources, Inc.LEJ2026-04-02
G5103358RENUVATANLight Sources, Inc.LEJ2026-04-02
G5103359RENUVATANLight Sources, Inc.LEJ2026-04-02
G5102275RENUVATANLight Sources, Inc.LEJ2026-03-30
G1501969BRILLIANCE ACTIVE BRONZERLight Sources, Inc.LEJ2026-03-27
G619370140SUPRAJW NORTH AMERICA, INC.LEJ2026-01-01
G619242500COSMEDICOJW NORTH AMERICA, INC.LEJ2025-12-01