Product areas
FDA product code distribution
Quanta System Spa
Country / region:Italy (IT)
510(k) submissions
38
Filtered: GEX
Latest clearance
2025-06-06
Product codes
1
GEX
510(k) submissions
38 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm | GEX | Class 2 | 2025-06-06 |
| K243588 | Single Use CO2 Laser Fiber (HAF005001) | GEX | Class 2 | 2025-02-19 |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | GEX | Class 2 | 2024-10-10 |
| K242251 | Litho 60; Litho 100; Litho 150 | GEX | Class 2 | 2024-09-03 |
| K232236 | Echo | GEX | Class 2 | 2023-10-20 |
| K223404 | Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V | GEX | Class 2 | 2023-01-20 |
| K220426 | Fiber Dust PRO | GEX | Class 2 | 2022-03-16 |
| K211228 | Rosso | GEX | Class 2 | 2022-02-02 |
| K210142 | Fiber Dust | GEX | Class 2 | 2021-03-11 |
| K202503 | Chrome | GEX | Class 2 | 2020-11-18 |
| K202041 | Opera Evo | GEX | Class 2 | 2020-10-15 |
| K201455 | Litho 150, Cyber Ho 150 | GEX | Class 2 | 2020-06-30 |
| K200234 | Surgical laser fibers | GEX | Class 2 | 2020-02-25 |
| K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 | GEX | Class 2 | 2020-02-21 |
| K192990 | Litho Evo | GEX | Class 2 | 2019-12-20 |
| K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | GEX | Class 2 | 2019-09-17 |
| K192160 | EVO Platform | GEX | Class 2 | 2019-09-06 |
| K182669 | Youlaser CO2 | GEX | Class 2 | 2018-10-17 |
| K181632 | Venacure 1470 Pro | GEX | Class 2 | 2018-09-17 |
| K180922 | Empower H100, Cyber Ho 100, Litho 100 | GEX | Class 2 | 2018-05-08 |
| K180426 | Empower H35 | GEX | Class 2 | 2018-03-16 |
| K180423 | Empower H65 | GEX | Class 2 | 2018-03-15 |
| K180158 | Surgical Laser fibers | GEX | Class 2 | 2018-02-14 |
| K173002 | 2940 nm Er:Yag Laser Handpiece | GEX | Class 2 | 2017-12-13 |
| K172376 | Discovery Pico, Discovery Pico Plus | GEX | Class 2 | 2017-10-19 |
| K172198 | 585 | GEX | Class 2 | 2017-10-17 |
| K172025 | Litho 60 | GEX | Class 2 | 2017-07-31 |
| K171945 | Discovery Pico, Discovery Pico Plus | GEX | Class 2 | 2017-07-28 |
| K171711 | Thunder, Thunder VT, Thunder HR | GEX | Class 2 | 2017-07-07 |
| K170331 | Cyber Ho | GEX | Class 2 | 2017-03-03 |
| K163222 | Discovery Pico Family | GEX | Class 2 | 2016-12-05 |
| K163009 | Litho | GEX | Class 2 | 2016-12-01 |
| K160368 | EVO platform | GEX | Class 2 | 2016-04-05 |
| K160513 | Quanta System Surgical Laser fibers | GEX | Class 2 | 2016-03-18 |
| K152714 | Quanta Forte | GEX | Class 2 | 2015-12-21 |
| K152012 | EVO platform | GEX | Class 2 | 2015-12-08 |
| K151629 | Guardian 1000 | GEX | Class 2 | 2015-10-27 |
| K152220 | MH01 | GEX | Class 2 | 2015-09-03 |
Company profile
- Canonical name
- Quanta System Spa
- Country
- Italy(IT)
Cited predicates
71- K203799
ProFlex CO2 Laser Fiber
- K201455
Litho 150, Cyber Ho 150
- K200234
Surgical laser fibers
- K131473
—
—
Not ingested - K160513
Quanta System Surgical Laser fibers
- K161257
MultiPulse HoPLUS
- K192600
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
- K182669
Youlaser CO2
- K203441
The Alma Hybrid Laser System
- K222221
DEKA HELIX
- K173002
2940 nm Er:Yag Laser Handpiece
- K160488
Cutera enlighten III Laser System
- K211228
Rosso
- K191842
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
- K192483
MeDioStar
- K170179
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
- K173002
2940 nm Er:Yag Laser Handpiece
- K202503
Chrome
- K192160
EVO Platform
- K060395
—
—
Not ingested - K210142
Fiber Dust
- K191842
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
- K160368
EVO platform
- K173002
2940 nm Er:Yag Laser Handpiece
- K133891
MULTIPULSE TM+1470
- K161257
MultiPulse HoPLUS
- K192600
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
- K160513
Quanta System Surgical Laser fibers
- K170366
Laser Peripherals, LLC Family of Bare Laser Fibers
- K180922
Empower H100, Cyber Ho 100, Litho 100
- K180426
Empower H35
- K172025
Litho 60
- K170121
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
- K180922
Empower H100, Cyber Ho 100, Litho 100
- K172376
Discovery Pico, Discovery Pico Plus
- K173002
2940 nm Er:Yag Laser Handpiece
- K123573
—
—
Not ingested - K140388
—
—
Not ingested - K172025
Litho 60
- K163009
Litho
- K140388
—
—
Not ingested - K172025
Litho 60
- K152714
Quanta Forte
- K152153
MicroSpot Handpiece
- K132806
—
—
Not ingested - K171945
Discovery Pico, Discovery Pico Plus
- K170597
PicoWay Laser System
- K013940
—
—
Not ingested - K133297
—
—
Not ingested - K170331
Cyber Ho
- K163222
Discovery Pico Family
- K162454
PicoWay Laser System
- K160368
EVO platform
- K163009
Litho
- K140388
—
—
Not ingested - K160368
EVO platform
- K140388
—
—
Not ingested - K141101
—
—
Not ingested - K131473
—
—
Not ingested - K143519
The MeDioStar NeXT Family
- K111303
—
—
Not ingested - K141403
—
—
Not ingested - K083889
—
—
Not ingested - K090235
—
—
Not ingested - K121162
—
—
Not ingested - K123168
—
—
Not ingested - K130356
—
—
Not ingested - K141425
—
—
Not ingested - K150326
PicoWay Laser System
- K110375
—
—
Not ingested - K101893
—
—
Not ingested
Quanta System Spa references 71 predicate/reference devices
Cited as predicate
63- K253951
Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
- K253765
VANISH PRO
- K253100
MultiPulse TFL
- K252787
Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)
- K252771
Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
- K243147
LGO-Surgical Laser Fibers
- K242987
Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
- K242534
HandPICO Fractional Laser Handpiece Tip
- K242293
Medical Thulium Fiber Laser Systems (UroFiber 60Q)
- K242251
Litho 60; Litho 100; Litho 150
- K242251
Litho 60; Litho 100; Litho 150
- K242251
Litho 60; Litho 100; Litho 150
- K242251
Litho 60; Litho 100; Litho 150
- K241930
Veincare
- K241527
Pastelle Pro
- K241527
Pastelle Pro
- K241092
Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
- K240983
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
- K240983
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
- K240983
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
- K240752
DEKA TORO
- K231718
Holmium Medical Laser
- K231718
Holmium Medical Laser
- K231718
Holmium Medical Laser
- K223404
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
- K223404
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
- K223404
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
- K220426
Fiber Dust PRO
- K213889
PicoStar
- K213726
PL-1 Skin Treatment System
- K213569
HOLLYWOOD SPECTRA Laser System
- K213350
mJOULE System and Accessories
- K211534
RevoLix HTL
- K202503
Chrome
- K202503
Chrome
- K202503
Chrome
- K202258
ERISE Laser handpiece
- K201455
Litho 150, Cyber Ho 150
- K200234
Surgical laser fibers
- K192990
Litho Evo
- K192990
Litho Evo
- K192856
MT One
- K192600
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
- K192600
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
- K192539
Deka Luxea
- K191942
MT One Diamond
- K191842
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
- K191842
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
- K180922
Empower H100, Cyber Ho 100, Litho 100
- K180426
Empower H35
- K180423
Empower H65
- K180350
Dornier Medilas H Solvo 35 Laser
- K173700
PICOPLUS Laser System
- K173677
InMode VLaze
- K173002
2940 nm Er:Yag Laser Handpiece
- K172413
MT ONE
- K172376
Discovery Pico, Discovery Pico Plus
- K172025
Litho 60
- K171945
Discovery Pico, Discovery Pico Plus
- K171711
Thunder, Thunder VT, Thunder HR
- K170936
Cutera enlighten III Laser System
- K170331
Cyber Ho
- K163222
Discovery Pico Family
63 submissions cite Quanta System Spa as a predicate