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Quanta System Spa

Italy · Samarate

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 2Class II 4Class III 0

plus 39 registration records and 57 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

17 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class III 5

31 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States39 registration records, 57 510(k), 0 PMA, 5 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: QUANTA SYSTEM, S.P.A. · QUANTA SYSTEM S.P.A. · QUANTA SYSTEM SPA

FDA 510(k) clearances by year

12006

22007

32008

22009

22010

22011

12012

42013

22014

42015

42016

72017

62018

32019

52020

12021

22022

22023

22024

22025

FDA listed device types

Extractor, Vacuum, Fetal 1Powered Laser Surgical Instrument 1Laparoscope, General & Plastic Surgery 1Pump, Portable, Aspiration (Manual Or Powered) 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1Tray, Surgical, Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240983	Discovery Pico; Discovery Pico Plus; Discovery Pico Derm	2025-06-06
US	K243588	Single Use CO2 Laser Fiber (HAF005001)	2025-02-19
US	K241092	Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT	2024-10-10
CA	82091	CYBER GREEN LASER SYSTEM	Class III
CA	83333	Q-PLUS C	Class III
CA	84539	LIGHT 4V LASER	Class III

Quanta System Spa

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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