Primo Dental Laser

Primary DI
08059340290079
Brand
Primo Dental Laser
Company
MEDENCY SRL
Model
Primo Triplo
Catalog number
MD.PRIMO.C.16.04.DEN
Device description
"Max power: 10WWavelength: 450/635/980nmThe model Primo Triplo of the family of medical devices ""Primo Dental Laser"" is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It’s a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts."
Published
2024-04-10
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
NVKLaser, Dental, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
NVKLaser, Dental, Soft TissueGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232222000Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.2023-11-27NVK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059340290079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059340290079080593402900798059340290079

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436042800
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059340290086Rapido Medical LaserRapido PodiaMD.RAPIDO.03.07.POD2026-05-06
08059340290246Rapido Medical LaserRapido DermaMD.RAPIDO.02.04.DER_012026-05-06
08059340290253Rapido Medical LaserRapido Derma MD.RAPIDO.10.07.DER_012026-05-06
08059340290260Rapido Medical LaserRapido Derma MD.RAPIDO.16.04.DER_012026-05-06
08059340290468Rapido Medical LaserRapido MEDMD.RAPIDO.10.07.SUR2026-05-06
08059340290475Rapido Medical LaserRapido MEDMD.RAPIDO.02.04.SUR 2026-05-06
08059340290499Rapido Medical LaserRapido ENTMD.RAPIDO.06.02.ENT 2026-05-06
08059340290505Rapido Medical LaserRapido ENTMD.RAPIDO.06.04.ENT2026-05-06
08059340290512Rapido Medical LaserRapido ENTMD.RAPIDO.01.03.ENT2026-05-06
08059340290536Rapido Medical LaserRapido DermaMD.RAPIDO.02.04.DER_022026-05-06
08059340290543Rapido Medical LaserRapido DermaMD.RAPIDO.10.07.DER_022026-05-06
08059340290550Rapido Medical LaserRapido Derma MD.RAPIDO.16.04.DER_02 2026-05-06
08059340291076Rapido Medical LaserRapido MEDMD.RAPIDO.28.04.SUR2026-05-06
08059340291083Rapido Medical LaserRapido PodiaMD.RAPIDO.29.04.POD2026-05-06
08059340290000Primo Dental LaserPrimoMD.PRIMO.A.02.04.DEN2024-04-10
08059340290017Primo Dental LaserPrimoMD.PRIMO.A.04.04.DEN2024-04-10
08059340290024Primo Dental LaserPrimo KomfortMD.PRIMO.D.01.03.DEN2024-04-10
08059340290031Primo Dental LaserPrimo LiteMD.PRIMO.B.02.01.DEN2024-04-10
08059340290048Primo Dental LaserPrimo BlueMD.PRIMO.E.06.02.DEN2024-04-10
08059340290055Primo Dental LaserPrimo TriploMD.PRIMO.C.18.04.DEN2024-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
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
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
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
08057017760528DEKA SMARTPERIOEL.EN. SPANVK2022-04-05
08059173390724Single 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
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07