FDA.reportPublic FDA data

Elements Synergy

Primary DI
EJKP100004099
Brand
Elements Synergy
Company
JK-Products GmbH
Model
JK 186 / 44-4 AC
Published
2025-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LEJBooth, Sun Tan

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220500000Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by ErgolineJk-Holding GmbH2022-07-01LEJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EJKP100004099PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
316232073
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EJKP100004142A0Ergoline Prestige Fusion EdgeMODEL-NO: JK 205 / 52-4 HLT AC2026-01-05
EJKP100004143A0Ergoline Prestige Synergy EDGEMODEL-NO: JK 205 / 52-4 HLT AC2026-01-05
EJKP100004088A0Recovery 7200 PFJK 158/RV32-0 VBR2025-12-10
EJKP100004182A0WellsystemHydrowave Pure2025-10-30
EJKP100004192A0Red Wave Recovery JK 194/RV32-10 VBR2025-10-30
EJKP100003993A0Planet Fitness 40/3 HLT Plus JK 191 / 40-3 HLT2025-04-30
EJKP100003996A0Ergolline Shine PLT JK 191 / 32-0 PLT2025-04-30
EJKP100003999A0Ergoline Pulse PLT JK 191 / 40-3 PLT AC2025-04-30
EJKP100004000A0Ergoline Spirit HLTJK 191 / 42-3 HLT AC2025-04-30
EJKP100004001A0Ergoline Spirit PLTJK 191 / 42-3 PLT AC2025-04-30
EJKP100004083A0Ergoline Spirit HLT JK 191 / 42-3 HLT2025-04-30
EJKP100004084A0Ergoline Spirit PLTJK 191 / 42-3 PLT2025-04-30
EJKP100004085A0Planet Fitness 40/3 HLT Plus JK 191 / 40-3 HLT AC2025-04-30
EJKP100004086A0Planet Fitness 40/1 PLT Plus JK 191 / 40-1 PLT AC2025-04-30
EJKP100004087A0Ergoline Pulse PLT JK 191 / 40-3 PLT2025-04-30
EJKP100004042A0Ergoline Vitality Pure Light 3 (10 min)JK 164 / 50-4 PLT-3 AC2024-02-28
EJKP100003952B0ReviveJK 194/RV32-0 VBR2023-12-01
EJKP100003960B0Revive RVT30JK 98 / RV 30-0 VBR E2023-12-01
EJKP100003973A0Revive PRO IRJK 194/RV32-10 VBR2023-11-15
EJKP100003439A0Ergoline SUNRISE 6200 Basic DesignJK 158 / 48-02018-03-13

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