Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Quanta System Spa

FDA 510(k) & PMA Approved Devices — 34 products

Total Devices34
Categories1
Latest FDA decision2025-06-06
TypeNumberDevice NameCodeDateActions
510(k) K240983 Discovery Pico; Discovery Pico Plus; Discovery Pico DermGEX2025-06-06 View
510(k) K243588 Single Use CO2 Laser Fiber (HAF005001)GEX2025-02-19 View
510(k) K241092 Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTGEX2024-10-10 View
510(k) K242251 Litho 60; Litho 100; Litho 150GEX2024-09-03 View
510(k) K232236 EchoGEX2023-10-20 View
510(k) K223404 Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VGEX2023-01-20 View
510(k) K220426 Fiber Dust PROGEX2022-03-16 View
510(k) K211228 RossoGEX2022-02-02 View
510(k) K210142 Fiber DustGEX2021-03-11 View
510(k) K202503 ChromeGEX2020-11-18 View
510(k) K202041 Opera EvoGEX2020-10-15 View
510(k) K201455 Litho 150, Cyber Ho 150GEX2020-06-30 View
510(k) K200234 Surgical laser fibersGEX2020-02-25 View
510(k) K192600 Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60GEX2020-02-21 View
510(k) K192990 Litho EvoGEX2019-12-20 View
510(k) K191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermGEX2019-09-17 View
510(k) K192160 EVO PlatformGEX2019-09-06 View
510(k) K182669 Youlaser CO2GEX2018-10-17 View
510(k) K181632 Venacure 1470 ProGEX2018-09-17 View
510(k) K180922 Empower H100, Cyber Ho 100, Litho 100GEX2018-05-08 View

Page 1 of 2

↑