Rapido Medical Laser

Primary DI
08059340290260
Brand
Rapido Medical Laser
Company
MEDENCY SRL
Model
Rapido Derma
Catalog number
MD.RAPIDO.16.04.DER_01
Device description
"Wavelength: 450/635/980nm, Max power: 10WThe model Rapido Derma of the family of medical devices ""Rapido Medical Laser"" is a laser medical device with surgical and therapeutic effects intended to be used in dermatology/aesthetics for skin diseases (Wrinkle*, Scars, Wart, Nevi, Acne, Stretch/Birthmarks), vascular treatments and plastic treatments (body lipolysis, face lypolisis, blepharoplasty, hyperhidrosis). 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
2026-05-06
Public version status
New
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
K240543000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240543000Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)Medency S.R.L.2024-10-24GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059340290260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059340290260080593402902608059340290260

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 incise, excise, ablate, 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal160 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal160 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
436042800
Device count
1
Serial number
true
Manufacturing date on label
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
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
08059340290062Primo Dental LaserPrimo TriploMD.PRIMO.C.17.04.DEN2024-04-10

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