# Quanta System Spa

- Location (FDA's records): Samarate, IT
- FDA decisions: 57 (2006–2025): 57 510(k) clearances
- Product codes: GEX (57)
- 510(k) review time since 2016: median 43 days, against 90 for FDA's reviews in the same codes and years (28 of 34 faster)
- Predicates its devices cite: 112 (46 its own); citations of its devices by later devices: 116 (46 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Asclepion Laser Technologies GmbH: 6 (https://510kreport.com/company/asclepion-laser-technologies)
- Cynosure, Inc.: 5 (https://510kreport.com/company/cynosure)
- Lumenis, Inc.: 5 (https://510kreport.com/company/lumenis)
- Biolitec, Inc.: 4 (https://510kreport.com/company/biolitec)
- Laser Peripherals, LLC: 3 (https://510kreport.com/company/laser-peripherals)
- El.En Electronic Engineering Spa: 3 (https://510kreport.com/company/el-en-electronic-engineering)
- Allmed Systems, Inc.: 3 (https://510kreport.com/company/allmed-systems)
- Innovaquartz, LLC: 2 (https://510kreport.com/company/innovaquartz)

## Firms that cite its devices most
- Biolitec, Inc.: 4 (https://510kreport.com/company/biolitec)
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.: 4 (https://510kreport.com/company/guangzhou-potent-medical-equipment-joint-stock)
- Sciton, Inc: 4 (https://510kreport.com/company/sciton)
- Allengers Global Healthcare Private Limited: 4 (https://510kreport.com/company/allengers-global-healthcare-private)
- M&T S.R.L.: 3 (https://510kreport.com/company/m-t)
- Cutera, Inc.: 3 (https://510kreport.com/company/cutera)
- El.En S.P.A.: 3 (https://510kreport.com/company/el-en)
- El.En Electronic Engineering Spa: 3 (https://510kreport.com/company/el-en-electronic-engineering)

## Its most-cited devices
- K100558: Quanta Diode Laser System (2010), cited by 14
- K202503: Chrome (2020), cited by 8
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), cited by 7
- K083613: Quanta System Polysurge Diode Laser Family (2008), cited by 6
- K152714: Quanta Forte (2015), cited by 5
- K073549: Q-Plus T (2008), cited by 5

## Recent decisions
- K240983: Discovery Pico; Discovery Pico Plus; Discovery Pico Derm (Jun 6, 2025)
- K243588: Single Use CO2 Laser Fiber (HAF005001) (Feb 19, 2025)
- K241092: Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (Oct 10, 2024)
- K242251: Litho 60; Litho 100; Litho 150 (Sep 3, 2024)
- K232236: Echo (Oct 20, 2023)
- K223404: Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V (Jan 20, 2023)
- K220426: Fiber Dust PRO (Mar 16, 2022)
- K211228: Rosso (Feb 2, 2022)

Source page: https://510kreport.com/company/quanta-system