Quanta System Spa

Country / region:Italy (IT)

510(k) submissions

Latest clearance

2025-06-06

Product codes

GEX

Cited as predicate

View list →

Product areas

FDA product code distribution

GEX38

510(k) submissions

38 total

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

K203799
—
—
Not ingested
K201455
—
—
Not ingested
K200234
—
—
Not ingested
K131473
—
—
Not ingested
K160513
—
—
Not ingested
K161257
—
—
Not ingested
K192600
—
—
Not ingested
K182669
Youlaser CO2
Quanta System Spa
K203441
The Alma Hybrid Laser System
Alma Lasers , Ltd.
K222221
DEKA HELIX
El.En Electronic Engineering Spa
K173002
—
—
Not ingested
K160488
—
—
Not ingested
K211228
—
—
Not ingested
K191842
—
—
Not ingested
K192483
—
—
Not ingested
K170179
—
—
Not ingested
K173002
—
—
Not ingested
K202503
—
—
Not ingested
K192160
—
—
Not ingested
K060395
—
—
Not ingested
K210142
—
—
Not ingested
K191842
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
Quanta System Spa
K160368
EVO platform
Quanta System Spa
K173002
2940 nm Er:Yag Laser Handpiece
Quanta System Spa
K133891
—
—
Not ingested
K161257
—
—
Not ingested
K192600
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
Quanta System Spa
K160513
—
—
Not ingested
K170366
—
—
Not ingested
K180922
—
—
Not ingested
K180426
—
—
Not ingested
K172025
—
—
Not ingested
K170121
—
—
Not ingested
K180922
—
—
Not ingested
K172376
—
—
Not ingested
K173002
—
—
Not ingested
K123573
—
—
Not ingested
K140388
—
—
Not ingested
K172025
—
—
Not ingested
K163009
—
—
Not ingested
K140388
—
—
Not ingested
K172025
—
—
Not ingested
K152714
—
—
Not ingested
K152153
—
—
Not ingested
K132806
—
—
Not ingested
K171945
Discovery Pico, Discovery Pico Plus
Quanta System Spa
K170597
PicoWay Laser System
Syneron Candela Corporation
K013940
—
—
Not ingested
K133297
—
—
Not ingested
K170331
Cyber Ho
Quanta System Spa
K163222
—
—
Not ingested
K162454
PicoWay Laser System
Syneron Candela Corporation
K160368
—
—
Not ingested
K163009
—
—
Not ingested
K140388
—
—
Not ingested
K160368
EVO platform
Quanta System Spa
K140388
—
—
Not ingested
K141101
—
—
Not ingested
K131473
—
—
Not ingested
K143519
The MeDioStar NeXT Family
Asclepion Laser Technologies GmbH
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
Candela Corporation
K110375
—
—
Not ingested
K101893
—
—
Not ingested

Quanta System Spa references 71 predicate/reference devices

Cited as predicate

K253951
Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Not ingested
K253765
VANISH PRO
Ddc Technologies, Inc.
K253100
MultiPulse TFL
Asclepion Laser Technologies GmbH
Not ingested
K252787
Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Not ingested
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)
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Not ingested
K243147
LGO-Surgical Laser Fibers
Light Guide Optics International , Ltd.
Not ingested
K242987
Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
Allengers Global Healthcare Private Limited
Not ingested
K242534
HandPICO Fractional Laser Handpiece Tip
Vydence Medical
Not ingested
K242293
Medical Thulium Fiber Laser Systems (UroFiber 60Q)
Rhein Laser Technologies Co., Ltd.
Not ingested
K242251
Litho 60; Litho 100; Litho 150
Quanta System Spa
Not ingested
K242251
Litho 60; Litho 100; Litho 150
Quanta System Spa
Not ingested
K242251
Litho 60; Litho 100; Litho 150
Quanta System Spa
Not ingested
K242251
Litho 60; Litho 100; Litho 150
Quanta System Spa
Not ingested
K241930
Veincare
Wontech Co., Ltd.
Not ingested
K241527
Pastelle Pro
Wontech Co., Ltd.
Not ingested
K241527
Pastelle Pro
Wontech Co., Ltd.
Not ingested
K241092
Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
Quanta System Spa
K240983
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
Quanta System Spa
Not ingested
K240983
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
Quanta System Spa
Not ingested
K240983
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
Quanta System Spa
Not ingested
K240752
DEKA TORO
El.En S.P.A.
K231718
Holmium Medical Laser
Allengers Global Healthcare Private Limited
Not ingested
K231718
Holmium Medical Laser
Allengers Global Healthcare Private Limited
Not ingested
K231718
Holmium Medical Laser
Allengers Global Healthcare Private Limited
Not ingested
K223404
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
Quanta System Spa
Not ingested
K223404
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
Quanta System Spa
Not ingested
K223404
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
Quanta System Spa
Not ingested
K220426
Fiber Dust PRO
Quanta System Spa
Not ingested
K213889
PicoStar
Asclepion Laser Technologies GmbH
Not ingested
K213726
PL-1 Skin Treatment System
AVAVA, Inc.
Not ingested
K213569
HOLLYWOOD SPECTRA Laser System
Lutronic Corporation
Not ingested
K213350
mJOULE System and Accessories
Sciton, Inc
Not ingested
K211534
RevoLix HTL
Lisa Laser Products GmbH
Not ingested
K202503
Chrome
Quanta System Spa
K202503
Chrome
Quanta System Spa
K202503
Chrome
Quanta System Spa
K202258
ERISE Laser handpiece
El.En Electronic Engineering Spa
Not ingested
K201455
Litho 150, Cyber Ho 150
Quanta System Spa
K200234
Surgical laser fibers
Quanta System Spa
Not ingested
K192990
Litho Evo
Quanta System Spa
Not ingested
K192990
Litho Evo
Quanta System Spa
Not ingested
K192856
MT One
M&T S.R.L.
Not ingested
K192600
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
Quanta System Spa
Not ingested
K192600
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
Quanta System Spa
Not ingested
K192539
Deka Luxea
El.En Electronic Engineering Spa
Not ingested
K191942
MT One Diamond
M&T S.R.L.
Not ingested
K191842
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
Quanta System Spa
Not ingested
K191842
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
Quanta System Spa
Not ingested
K180922
Empower H100, Cyber Ho 100, Litho 100
Quanta System Spa
Not ingested
K180426
Empower H35
Quanta System Spa
Not ingested
K180423
Empower H65
Quanta System Spa
Not ingested
K180350
Dornier Medilas H Solvo 35 Laser
Dornier Medtech America
Not ingested
K173700
PICOPLUS Laser System
Lutronic Corporation
Not ingested
K173677
InMode VLaze
Inmode MD , Ltd.
Not ingested
K173002
2940 nm Er:Yag Laser Handpiece
Quanta System Spa
Not ingested
K172413
MT ONE
M&T S.R.L.
Not ingested
K172376
Discovery Pico, Discovery Pico Plus
Quanta System Spa
K172025
Litho 60
Quanta System Spa
K171945
Discovery Pico, Discovery Pico Plus
Quanta System Spa
Not ingested
K171711
Thunder, Thunder VT, Thunder HR
Quanta System Spa
Not ingested
K170936
Cutera enlighten III Laser System
Cutera, Inc.
Not ingested
K170331
Cyber Ho
Quanta System Spa
Not ingested
K163222
Discovery Pico Family
Quanta System Spa

63 submissions cite Quanta System Spa as a predicate