FDA.reportPublic FDA data

Primo Dental Laser

Primary DI
08059340290055
Brand
Primo Dental Laser
Company
MEDENCY SRL
Model
Primo Triplo
Catalog number
MD.PRIMO.C.18.04.DEN
Device description
"Max power: 10WWavelength: 635/810/980nmThe 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
08059340290055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059340290055080593402900558059340290055

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
08059340290062Primo Dental LaserPrimo TriploMD.PRIMO.C.17.04.DEN2024-04-10

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