510(k) Report

510(k) · Cleared

Cleared

Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V

K223404510(k) SpecialCleared Jan 20, 202372-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Quanta System Spa · GEX Powered Laser Surgical Instrument

Cleared on Jan 20, 2023 as substantially equivalent to K192160 (Quanta System Spa, 2019) and 1 other predicate after a 72-day review. Its family tree reaches back 27 generations to 1995.

Decided
Jan 20, 2023
Review
72 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
2

Its longest line of descent runs back 27 generations to K943450 (1995). 300 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2019: 1 other ancestor2015: 1 other ancestor2014: 1 other ancestor2013: 1 other ancestor2012: 2 other ancestors2009: 2 other ancestors2002: 35 other ancestors2008: 3 other ancestors2007: 2 other ancestors2006: 6 other ancestors2005: 10 other ancestors2004: 17 other ancestors2003: 24 other ancestors1999: 11 other ancestors1997: 24 other ancestors2001: 26 other ancestors2000: 26 other ancestors1994: 12 other ancestors1998: 15 other ancestors1996: 17 other ancestors1995: 12 other ancestors1993: 8 other ancestors1991: 4 other ancestors1990: 3 other ancestors1988: 2 other ancestors1992: 3 other ancestors1989: 2 other ancestors1982: 1 other ancestor1980: 1 other ancestor1985: 1 other ancestorReference device: K060395 · Cryo, Model V6.0 · Zimmer Elektromedizin GmbH · 2006Reference device: K173002 · 2940 nm Er:Yag Laser Handpiece · Quanta System Spa · 2017K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K051214 · Aluma Skin Renewal System · Lumenis, Inc. · 2005K060448 · Lumenis One Family of Systems; Lumenis One. · Lumenis, Ltd. · 2006K072564 · Alma Lasers Harmony XL Multi-Application Platform · Alma Lasers, Ltd. · 2008K083899 · Revlite Q-Switched ND:Yag Laser System · Hoya Conbio, Inc. · 2009K103118 · Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor · Hoya Photonics, Inc. · 2010 · recalledK121346 · Picosure Workstation · Cynosure, Inc. · 2012K142372 · Pico Way Laser System · Candela Corpation · 2014K150326 · PicoWay Laser System · Candela Corporation · 2015×2: 2 generations cleared close together, K152012 (2015), K160368 (2016) K163222 · Discovery Pico Family · Quanta System Spa · 2016×2: 2 generations cleared close together, K171945 (2017), K172376 (2017) K191842 · Discovery Pico, Discovery Pico Plus, Discovery Pico Derm · Quanta System Spa · 2019K202503 · Chrome · Quanta System Spa · 202019801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor7 generations back: 1 other ancestor8 generations back: 7 other ancestors9 generations back: 13 other ancestors10 generations back: 29 other ancestors11 generations back: 45 other ancestors12 generations back: 63 other ancestors13 generations back: 46 other ancestors14 generations back: 36 other ancestors15 generations back: 11 other ancestors16 generations back: 11 other ancestors17 generations back: 9 other ancestors18 generations back: 1 other ancestor K202503 · Chrome · Quanta System Spa · 2020K191842 · Discovery Pico, Discovery Pico Plus, Discovery Pico Derm · Quanta System Spa · 2019K172376 · Discovery Pico, Discovery Pico Plus · Quanta System Spa · 2017K171945 · Discovery Pico, Discovery Pico Plus · Quanta System Spa · 2017K163222 · Discovery Pico Family · Quanta System Spa · 2016K160368 · EVO platform · Quanta System Spa · 2016K152012 · EVO platform · Quanta System Spa · 2015K150326 · PicoWay Laser System · Candela Corporation · 2015K142372 · Pico Way Laser System · Candela Corpation · 2014K121346 · Picosure Workstation · Cynosure, Inc. · 2012K103118 · Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor · Hoya Photonics, Inc. · 2010 · recalledK083899 · Revlite Q-Switched ND:Yag Laser System · Hoya Conbio, Inc. · 2009K072564 · Alma Lasers Harmony XL Multi-Application Platform · Alma Lasers, Ltd. · 2008K060448 · Lumenis One Family of Systems; Lumenis One. · Lumenis, Ltd. · 2006K051214 · Aluma Skin Renewal System · Lumenis, Inc. · 2005K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−25−20−15−10−50
  1. Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 23 generations between
  3. 3 generations backK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
  4. 2 generations backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
  5. 1 generation backK202503 ChromeQuanta System Spa · 2020
  6. This deviceK223404 Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa · 2023
Show all 27 generations
  1. Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 26 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 25 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 24 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 23 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 22 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 21 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 20 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 19 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 18 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 17 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 16 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 15 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
  14. 14 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
  15. 13 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
  16. 12 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
  17. 11 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
  18. 10 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
  19. 9 generations backK142372 Pico Way Laser SystemCandela Corpation · 2014
  20. 8 generations backK150326 PicoWay Laser SystemCandela Corporation · 2015
  21. 7 generations backK152012 EVO platformQuanta System Spa · 2015
  22. 6 generations backK160368 EVO platformQuanta System Spa · 2016
  23. 5 generations backK163222 Discovery Pico FamilyQuanta System Spa · 2016
  24. 4 generations backK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
  25. 3 generations backK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
  26. 2 generations backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
  27. 1 generation backK202503 ChromeQuanta System Spa · 2020
  28. This deviceK223404 Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−27K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−26K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−25K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−24K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−23K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−22K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−21K000944Thermage Thermacool SystemThermage, Inc.2000—
−20K013034Modification to: Thermacool IiaThermage, Inc.2001—
−19K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−18K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−17K030142Thermacool TC SystemThermage, Inc.2003—
−16K031671Polaris WRSyneron Medical, Ltd.2003—
−15K051214Aluma Skin Renewal SystemLumenis, Inc.2005—
−14K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006—
−13K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008—
−12K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009—
−11K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.20101
−10K121346Picosure WorkstationCynosure, Inc.2012—
−9K142372Pico Way Laser SystemCandela Corpation2014—
−8K150326PicoWay Laser SystemCandela Corporation2015—
−7K152012EVO platformQuanta System Spa2015—
−6K160368EVO platformQuanta System Spa2016—
−5K163222Discovery Pico FamilyQuanta System Spa2016—
−4K171945Discovery Pico, Discovery Pico PlusQuanta System Spa2017—
−3K172376Discovery Pico, Discovery Pico PlusQuanta System Spa2017—
−2K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa2019—
−1K202503ChromeQuanta System Spa2020—
0 (this device)K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198210
198510
198820
198920
199030
199140
199230
199380
1994120
1995120
1996170
1997240
1998150
1999110
2000260
2001260
2002350
2003240
2004170
2005100
200660
200720
200830
200920
201220
201310
201410
201510
201910
FIG. 1 — Lineage of K223404, 1995–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

  1. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K192160EVO Platform
Summary page 5
…Regulation Number: 21 CFR 878.4810 Product Code: GEX Basis for submission: Device technical modifications Predicate device Evo Platform (K192160) and Chrome (K202503) manufactured by Quanta System. Suprema family devices are…
Quanta System Spa2019—
*K202503Chrome
Summary page 5
…21 CFR 878.4810 Product Code: GEX Basis for submission: Device technical modifications Predicate device Evo Platform (K192160) and Chrome (K202503) manufactured by Quanta System. Suprema family devices are derived from legally…
Quanta System Spa2020—
†K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH2006—
†K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa2017—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 28 years and passes through 12 companies; a new generation was cleared every 9 months on median.
  • 15 of the 300 ancestors have a recall of any class.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

Suprema Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows. 1064 nm (pulsed) Dermatology/Plastic Surgery: Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts…

Read the full statement (581 words)

Suprema Family is intended for use in aesthetic, cosmetic and surgical applications requiring

incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical

specialties of dermatology, general, plastic and oral surgery as follows.

1064 nm (pulsed)

Dermatology/Plastic Surgery:

Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to,

port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins

and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae

and psoriasis.

The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to,

lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi,

chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and

perioral wrinkles.

The laser is also indicated for the treatment of facial wrinkles.

Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable

long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable

reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the

completion of a treatment regime.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where

vascularity is an integral part of the scar.

The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that

would potentially benefit from aggressive treatment, and for patients with lesions that have not

responded to other laser treatments.

It is indicated for use on all skin types (Fitzpatrick 1-VI) including tanned skin, and the removal and

permanent reduction of unwanted hair in Fitzpatrick 1-VI, including suntanned skin types.

532 nm (pulsed)

Intended for the coagulation and hemostasis of vascular lesions.

Dermatology/Plastic Surgery:

For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including

but not limited to the following general categories: vascular lesions [angiomas, hemangiomas (port

wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign

pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae,

skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching,

flattening, reduction of lesion size).

755 nm (pulsed)

Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as

long-term stable reduction in the number of hairs re-growing when measured 6, 9, or 12 months

after the completion of a treatment regime. It is used for all skin types (Fitzpatrick 1-VI) including

tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and

wrinkles.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs

regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia),

photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign

pigmented lesions.

IPL 400-1200nm

Indicated for inflammatory acne (acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in Suprema Family is to provide cooling of the

skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of

higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the

potential side effects of laser treatments.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K223404: Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223404

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026