FDA.reportPublic FDA data

Original Hanau

Primary DI
54054657600237
Brand
Original Hanau
Company
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Model
Strahler OH M 50/100 EF
Catalog number
8002 6750
Device description
UV - Tanning lamp
Published
2016-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
K151674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151674000Ultraviolet Sun Tanning LampG.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh2015-10-20LEJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14054657500232PackageGS11In Commercial Distribution
54054657600237PackageGS1100In Commercial Distribution
04054657500235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405465750023214054657500232
5405465760023754054657600237
04054657500235040546575002354054657500235

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4961814902316info@original-hanau.com

Regulatory Flags#

DUNS number
312827900
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
04054657500228Original HanauStrahler OH M 400 SF4500 64072016-12-13
04054657500235Original HanauStrahler OH M 50/100 EF8002 67502016-12-13
04054657500259Original HanauStrahler OH M 500 SF4500 64092017-02-28
04054657500273Original HanauStrahler OH M 600 EF8002 31082017-02-28
04054657500549Original HanauStrahler OH N 70/120 EF8000 85992016-12-13
04054657500556CosmedicoStrahler SUPRA Q-250 BPR8004 13102017-02-28
04054657500587Original HanauStrahler OH C 460 SF5606 98992017-02-28
04054657500594Original HanauStrahler OH M 60/80 EF8002 15172017-02-28
04054657500600Original HanauStrahler OH N 24/50 EF4500 65442017-02-28
04054657500617Original HanauStrahler OH C 400 EF8000 98982017-02-28
04054657500624Original HanauStrahler OH N 50/100 EF+4500 64112017-02-28
04054657500631Original HanauStrahler Varius EF vst8002 65002017-02-28
04054657500648Original HanauStrahler OH N 800 SF8001 53552017-02-28
04054657500655Original HanauStrahler OH C 560 SF8000 44572017-02-28
04054657500037MegalineStrahler BQ 460 SF8002 61142017-02-28
04054657500051JKStrahler JK 30/60 EF8003 09182017-02-28
04054657500198Original HanauStrahler OH C 561 LF8000 44562017-02-28
54054657600220Original HanauStrahler OH M 400 SF4500 64072016-12-13
14054657500256Original HanauStrahler OH M 500 SF4500 64092017-02-28
14054657500270Original HanauStrahler OH M 600 EF8002 31082017-02-28

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