Quanta System, S.p.A.
FDA Regulatory Profile
Quanta System, S.p.A. appears in FDA public data with 6 recalls, 57 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (Z-1843-2021, Class II) was initiated on April 27, 2021. Its most recent 510(k) clearance was granted on June 6, 2025.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 57
- Inspections
- 1
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1843-2021 | Class II | Quanta System Sterile Optical Laser Fiber, single use | April 27, 2021 |
| Z-1842-2021 | Class II | Olympus Sterile Optical Laser Fiber, single use and reusable | April 27, 2021 |
| Z-1844-2021 | Class II | Quanta System Sterile Optical Laser Fiber, reusable | April 27, 2021 |
| Z-0692-2013 | Class II | Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagu | November 7, 2012 |
| Z-0691-2013 | Class II | Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesio | November 7, 2012 |
| Z-0693-2013 | Class II | Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coag | November 7, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm | June 6, 2025 |
| K243588 | Single Use CO2 Laser Fiber (HAF005001) | February 19, 2025 |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | October 10, 2024 |
| K242251 | Litho 60; Litho 100; Litho 150 | September 3, 2024 |
| K232236 | Echo | October 20, 2023 |
| K223404 | Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V | January 20, 2023 |
| K220426 | Fiber Dust PRO | March 16, 2022 |
| K211228 | Rosso | February 2, 2022 |
| K210142 | Fiber Dust | March 11, 2021 |
| K202503 | Chrome | November 18, 2020 |
| K202041 | Opera Evo | October 15, 2020 |
| K201455 | Litho 150, Cyber Ho 150 | June 30, 2020 |
| K200234 | Surgical laser fibers | February 25, 2020 |
| K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 | February 21, 2020 |
| K192990 | Litho Evo | December 20, 2019 |
| K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | September 17, 2019 |
| K192160 | EVO Platform | September 6, 2019 |
| K182669 | Youlaser CO2 | October 17, 2018 |
| K181632 | Venacure 1470 Pro | September 17, 2018 |
| K180922 | Empower H100, Cyber Ho 100, Litho 100 | May 8, 2018 |