FDA.reportPublic FDA data

N/A

Primary DI
18809909351072
Brand
N/A
Company
UNILAM CO.,LTD.
Model
URI SUV 620/KT/BC35
Published
2022-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K143043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143043000Tanning LampUnilam Co., Ltd.2015-04-02LEJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809909351072PackageGS112In Commercial Distribution
08809909351075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880990935107218809909351072
08809909351075088099093510758809909351075

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

Contacts#

Phone, Email table
PhoneEmail
+82553722509whdudqn1@unilam.co.kr

Regulatory Flags#

DUNS number
688290824
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
08809909351884N/ALET SUV 800-1000/KT/GYU2025-05-22
08809909353444N/ALET SUV 2000/KT/H2024-08-05
18809909353441N/ALET SUV 2000/KT/H2024-08-05
08809909353437N/AURI SUV 2000/KT/H2024-06-14
18809909353434N/AURI SUV 2000/KT/H2024-06-14
08809909351327N/AURI SUV 2000/H2024-03-08
18809909351324N/AURI SUV 2000/H2024-03-08
08809909353406N/AFST SUV 300-500/KT/GYU/R2023-09-14
08809909353420N/AFST SUV 600-800/KT/GYU/R2023-09-14
18809909353427N/AFST SUV 600-800/KT/GYU/R2023-09-14
08809909353413N/AFST SUV 400/KT/R2023-09-14
08809909350702N/AURI SUV 250/KT/SE2022-10-07
08809909350818N/AURI SUV 300-500/KT/G2022-10-13
08809909350931N/AURI SUV 400/KT2023-01-09
08809909350986N/AURI SUV 500/KT/WL/B262022-11-02
08809909351068N/AURI SUV 620/KT2022-10-17
08809909351075N/AURI SUV 620/KT/BC352022-11-02
08809909351099N/AURI SUV 620 DE2022-10-17
08809909351105N/AURI SUV 650/KT/B232022-10-17
08809909351310N/AURI SUV 1400/KT/IB382022-10-17

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