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Quanta System, S.p.A.

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
57
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1844-2021Class IIQuanta System Sterile Optical Laser Fiber, reusableApril 27, 2021
Z-1843-2021Class IIQuanta System Sterile Optical Laser Fiber, single useApril 27, 2021
Z-1842-2021Class IIOlympus Sterile Optical Laser Fiber, single use and reusableApril 27, 2021
Z-0692-2013Class IIEterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; PhotocoaguNovember 7, 2012
Z-0691-2013Class IIQ-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesioNovember 7, 2012
Z-0693-2013Class IIUltrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: CoagNovember 7, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermJune 6, 2025
K243588Single Use CO2 Laser Fiber (HAF005001)February 19, 2025
K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTOctober 10, 2024
K242251Litho 60; Litho 100; Litho 150September 3, 2024
K232236EchoOctober 20, 2023
K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VJanuary 20, 2023
K220426Fiber Dust PROMarch 16, 2022
K211228RossoFebruary 2, 2022
K210142Fiber DustMarch 11, 2021
K202503ChromeNovember 18, 2020
K202041Opera EvoOctober 15, 2020
K201455Litho 150, Cyber Ho 150June 30, 2020
K200234Surgical laser fibersFebruary 25, 2020
K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60February 21, 2020
K192990Litho EvoDecember 20, 2019
K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermSeptember 17, 2019
K192160EVO PlatformSeptember 6, 2019
K182669Youlaser CO2October 17, 2018
K181632Venacure 1470 ProSeptember 17, 2018
K180922Empower H100, Cyber Ho 100, Litho 100May 8, 2018