MEDENCY SRL

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3030090167	3030090167	MEDENCY SRL	1	N	2026-01-01	Via degli Ontani, 48 - Vicenza (Italy) Vicenza Veneto IT 36100

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
322955	1807813437	K240543	Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)	GEX	2024-10-24
322955	1903238057	K232222	Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)	NVK	2023-11-27
322955	1688551438

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEX	1	2024-10-24
NVK	1	2023-11-27

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
Primo Dental Laser - "Max power: 10WWavelength: 980nmThe model Primo 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. "
MEDENCY SRL
2024-04-10
Primo Dental Laser - "Max power: 10WWavelength: 940nmThe model Primo 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."
MEDENCY SRL
2024-04-10
Primo Dental Laser - "Max power: 7WWavelength: 810nmThe model Primo Komfort 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."
MEDENCY SRL
2024-04-10
Primo Dental Laser - "Max power: 2.5WWavelength: 980nmThe model Primo Lite 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."
MEDENCY SRL
2024-04-10
Primo Dental Laser - "Max power: 3WWavelength: 450nmThe model Primo Blue 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."
MEDENCY SRL
2024-04-10
Primo Dental Laser - "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."
MEDENCY SRL
2024-04-10
Primo Dental Laser - "Max power: 10WWavelength: 450/635/810nmThe 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."
MEDENCY SRL
2024-04-10
Primo Dental Laser - "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."
MEDENCY SRL
2024-04-10