Company ยท IT
Quanta System Spa
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2025. Name variants (Inc, Corp, punctuation) are merged.
57510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 63 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 6, 2025 | K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm Quanta System Spa, IT | GEX |
| Feb 19, 2025 | K243588 | Single Use CO2 Laser Fiber (HAF005001) Quanta System Spa, IT | GEX |
| Oct 10, 2024 | K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT Quanta System Spa, IT | GEX |
| Sep 3, 2024 | K242251 | Litho 60; Litho 100; Litho 150 Quanta System Spa, IT | GEX |
| Oct 20, 2023 | K232236 | Echo Quanta System Spa, IT | GEX |
| Jan 20, 2023 | K223404 | Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V Quanta System Spa, IT | GEX |
| Mar 16, 2022 | K220426 | Fiber Dust PRO Quanta System Spa, IT | GEX |
| Feb 2, 2022 | K211228 | Rosso Quanta System Spa, IT | GEX |
| Mar 11, 2021 | K210142 | Fiber Dust Quanta System Spa, IT | GEX |
| Nov 18, 2020 | K202503 | Chrome Quanta System Spa, IT | GEX |
| Oct 15, 2020 | K202041 | Opera Evo Quanta System Spa, IT | GEX |
| Jun 30, 2020 | K201455 | Litho 150, Cyber Ho 150 Quanta System Spa, IT | GEX |
| Feb 25, 2020 | K200234 | Surgical laser fibers Quanta System Spa, IT | GEX |
| Feb 21, 2020 | K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 Quanta System Spa, IT | GEX |
| Dec 20, 2019 | K192990 | Litho Evo Quanta System Spa, IT | GEX |
| Sep 17, 2019 | K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm Quanta System Spa, IT | GEX |
| Sep 6, 2019 | K192160 | EVO Platform Quanta System Spa, IT | GEX |
| Oct 17, 2018 | K182669 | Youlaser CO2 Quanta System Spa, IT | GEX |
| Sep 17, 2018 | K181632 | Venacure 1470 Pro Quanta System Spa, IT | GEX |
| May 8, 2018 | K180922 | Empower H100, Cyber Ho 100, Litho 100 Quanta System Spa, IT | GEX |
| Mar 16, 2018 | K180426 | Empower H35 Quanta System Spa, IT | GEX |
| Mar 15, 2018 | K180423 | Empower H65 Quanta System Spa, IT | GEX |
| Feb 14, 2018 | K180158 | Surgical Laser fibers Quanta System Spa, IT | GEX |
| Dec 13, 2017 | K173002 | 2940 nm Er:Yag Laser Handpiece Quanta System Spa, IT | GEX |
| Oct 19, 2017 | K172376 | Discovery Pico, Discovery Pico Plus Quanta System Spa, IT | GEX |
| Oct 17, 2017 | K172198 | 585 Quanta System Spa, IT | GEX |
| Jul 31, 2017 | K172025 | Litho 60 Quanta System Spa, IT | GEX |
| Jul 28, 2017 | K171945 | Discovery Pico, Discovery Pico Plus Quanta System Spa, IT | GEX |
| Jul 7, 2017 | K171711 | Thunder, Thunder VT, Thunder HR Quanta System Spa, IT | GEX |
| Mar 3, 2017 | K170331 | Cyber Ho Quanta System Spa, IT | GEX |
| Dec 5, 2016 | K163222 | Discovery Pico Family Quanta System Spa, IT | GEX |
| Dec 1, 2016 | K163009 | Litho Quanta System Spa, IT | GEX |
| Apr 5, 2016 | K160368 | EVO platform Quanta System Spa, IT | GEX |
| Mar 18, 2016 | K160513 | Quanta System Surgical Laser fibers Quanta System Spa, IT | GEX |
| Dec 21, 2015 | K152714 | Quanta Forte Quanta System Spa, IT | GEX |
| Dec 8, 2015 | K152012 | EVO platform Quanta System Spa, IT | GEX |
| Oct 27, 2015 | K151629 | Guardian 1000 Quanta System Spa, IT | GEX |
| Sep 3, 2015 | K152220 | MH01 Quanta System Spa, IT | GEX |
| Aug 8, 2014 | K141101 | LITHO Quanta System Spa, IT | GEX |
| Aug 7, 2014 | K141403 | LITHO DK30 Quanta System Spa, IT | GEX |
| Oct 24, 2013 | K131473 | (QUANTA SYSTEM) SURGICAL LASER FIBERS Quanta System Spa, IT | GEX |
| Jul 3, 2013 | K131081 | CYBER TM FAMILY Quanta System Spa, IT | GEX |
| Jul 2, 2013 | K130256 | MDK MULTI-APPLICATIONS PLATFORM Quanta System Spa, IT | GEX |
| Apr 15, 2013 | K123573 | YOULASER CO2 LASER Quanta System Spa, IT | GEX |
| Dec 20, 2012 | K123168 | Q-PLUS T+ IPL LASER SYSTEM Quanta System Spa, IT | GEX |
| Aug 25, 2011 | K111592 | YOULASER CO2 LASER SYSTEM Quanta System Spa, IT | GEX |
| Jan 20, 2011 | K103539 | QUANTA SYSTEM DUOLITE Quanta System Spa, IT | GEX |
| Dec 10, 2010 | K102749 | QUANTA CYBER TM 150W Quanta System Spa, IT | GEX |
| Jul 22, 2010 | K100558 | QUANTA DIODE LASER SYSTEM Quanta System Spa, IT | GEX |
| Jul 9, 2009 | K091909 | LITHO LASER SYSTEM Quanta System Spa, IT | GEX |
Newest 50 of 57.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2021 | Quanta System, S.p.A. Quanta System Sterile Optical Laser Fiber, reusable Terminated |
GEX | K160513 |
| Apr 27, 2021 | Quanta System, S.p.A. Quanta System Sterile Optical Laser Fiber, single use Terminated |
GEX | K131473 |
| Apr 27, 2021 | Quanta System, S.p.A. Olympus Sterile Optical Laser Fiber, single use and reusable Terminated |
GEX | K180158 |
| Jan 17, 2013 | Quanta System, S.p.A. Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument.
Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangi Terminated |
GEX | K070805 K083207 |
| Jan 17, 2013 | Quanta System, S.p.A. Eterna Giovinezza System, Powered Laser Surgical Instrument.
Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and Terminated |
GEX | K051113 |
| Jan 17, 2013 | Quanta System, S.p.A. Q-Plus T Powered Laser Surgical Instrument
Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of s Terminated |
GEX | K073549 K123168 |