FDA.reportPublic FDA data

MEDENCY SRL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30300901673030090167MEDENCY SRL1N2026-01-01Via degli Ontani, 48 - Vicenza (Italy) Vicenza Veneto IT 36100

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3229551807813437K240543Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)GEX2024-10-24
3229551903238057K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)NVK2023-11-27
3229551688551438

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX12024-10-24
NVK12023-11-27

GUDID#

Rapido Medical Laser - "Wavelength: 1064nm, Max power: 8WThe model Rapido Podia of the family of medical devices ""Rapido Medical Laser"" is a laser medical device with surgical and therapeutic effects intended to be used in podiatry, including the treatment of onychomycosis and diabetic foot wounds. It’s also intended for traumatology and pain therapy. 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 1470nm, Max power: 8WThe 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 1470nm, Max power:8WThe model Rapido MED of the family of medical devices ""Rapido Medical Laser"" is a laser medical device with surgical and therapeutic effects intended to be used in general surgery, including urology, gynaecology, proctology, phlebology and percutaneous laser disc decompression (PLDD). It’s also intended to be used in the oral therapy. 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 980nm, Max power: 10WThe model Rapido MED of the family of medical devices ""Rapido Medical Laser"" is a laser medical device with surgical and therapeutic effects intended to be used in general surgery, including urology, gynaecology, proctology, phlebology and percutaneous laser disc decompression (PLDD). It’s also intended to be used in the oral therapy. 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 450nm, Max power: 3WThe model Rapido ENT of the family of medical devices ""Rapido Medical Laser"" is a laser medical device with surgical and therapeutic effects intended to be used in ENT for ear/nose/throat pathologies including Roncopathy, Dacryocystorhinostomy (DCR). It’s also intended to be used in the oral therapy. 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 450nm, Max power: 10WThe model Rapido ENT of the family of medical devices ""Rapido Medical Laser"" is a laser medical device with surgical and therapeutic effects intended to be used in ENT for ear/nose/throat pathologies including Roncopathy, Dacryocystorhinostomy (DCR). It’s also intended to be used in the oral therapy. 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 810nm, Max power: 7WThe model Rapido ENT of the family of medical devices ""Rapido Medical Laser"" is a laser medical device with surgical and therapeutic effects intended to be used in ENT for ear/nose/throat pathologies including Roncopathy, Dacryocystorhinostomy (DCR). It’s also intended to be used in the oral therapy. 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 1470nm, Max power: 8W The 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 980nm/1470nm, Max power: 10WThe model Rapido MED of the family of medical devices ""Rapido Medical Laser"" is a laser medical device with surgical and therapeutic effects intended to be used in general surgery, including urology, gynaecology, proctology, phlebology and percutaneous laser disc decompression (PLDD). It’s also intended to be used in the oral therapy. 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."

MEDENCY SRL

2026-05-06

Rapido Medical Laser - "Wavelength: 810nm/1064nm, Max power: 10WThe model Rapido Podia of the family of medical devices ""Rapido Medical Laser"" is a laser medical device with surgical and therapeutic effects intended to be used in podiatry, including the treatment of onychomycosis and diabetic foot wounds. It’s also intended for traumatology and pain therapy. 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."

MEDENCY SRL

2026-05-06