FDA.reportPublic FDA data

Splendor X

Primary DI
08052049500333
Brand
Splendor X
Company
BIOS SRL
Model
Splendor X Alex
Published
2025-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243445000Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.2024-12-30GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052049500333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052049500333080520495003338052049500333

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod, or a fibre doped with a glass/crystal element (known as fibre laser), to emit a high-power laser beam intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, acne treatment, and/or lesion/hair/tattoo removal; some types may also be used for coagulation/haemostasis procedures; it is not intended for hair loss therapy. It typically includes a light source, laser beam delivery/positioning device(s), user interface, and controls/foot-switch; it does not include frequency-doubling technology.

Regulatory Flags#

DUNS number
443571203
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052049500326Splendor XSplendor X Alex+Nd:YAG2025-01-16
08052049500340Splendor XSplendor X Alex22025-01-16
08052049500357Splendor XSplendor X Nd:YAG2025-01-16
08052049500234Splendor XSplendor X Alex+Nd:YAG2024-07-02
08052049500241Splendor XSplendor X Alex2024-07-02
08052049500258Splendor XSplendor X Alex22024-07-02
08052049500265Splendor XSplendor X Nd:YAG2024-07-02
08052049500029SQUARE EPIL ALEX + Nd:YAGAPMD122.US2017-02-15
08052049500067SPLENDOR X ALEX + Nd:YAGAPMD122.SPX2019-05-06
08052049500289OptiPLUSAPMD145-1ch.US-OptiPLUS2023-11-06
08052049500272OptiPLUSAPMD145-1ch.US-OptiPLUS2023-08-23
08052049500227OptiStreamAPMD145-1ch.US-Opti2022-10-04
08052049500210NUERA TIGHT 1ch Paris EditionAPMD145-1ch.US-PH2022-07-06
08052049500135FEMINESS tipAE02042021-11-02
08052049500197FEMINESSAPMD145-FEM.US2021-11-02
08052049500005THERMI 250APMD115C2016-09-29
08052049500043BIOREVITAL RF MEDAPMD75CA.1202018-06-01
08052049500050NUERAAPMD1302018-06-06
08052049500111NUERA TIGHTAPMD145-1ch.US2020-06-29
08052049500104NUERA TIGHTAPMD1402019-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08059173391882Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391912Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391943Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391196Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2020-06-09
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390786Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15