510(k) · Cleared
ClearedChrome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quanta System Spa · GEX Powered Laser Surgical Instrument
Cleared on Nov 18, 2020 as substantially equivalent to K191842 (Quanta System Spa, 2019) after a 79-day review. Its family tree reaches back 26 generations to 1995. 12 later devices descend from it.
- Decided
- Nov 18, 2020
- Review
- 79 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 26 generations to K943450 (1995). 298 ancestors in all, the oldest K800617 (1980). 12 later devices descend from it, 8 citing it directly.
- Root · 26 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations between
- 3 generations backK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 2 generations backK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 1 generation backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
- This deviceK202503 ChromeQuanta System Spa · 2020
- Descendant · cites it directly · 7 of its ownK213569 HOLLYWOOD SPECTRA Laser SystemLutronic Corporation · 2022
- Descendant · cites it directly · 3 of its ownK241527 Pastelle ProWontech Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK233473 Deka LotusEl.En S.P.A. · 2024
- Descendant · 2 generations on · 0 of its ownK260256 Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253765 Vanish ProDdc Technologies, Inc. · 2026
Show all 26 generations
- Root · 26 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 25 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 24 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 22 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 21 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 20 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 19 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 18 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 17 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 15 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 14 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 13 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 12 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 11 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 10 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 9 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 8 generations backK142372 Pico Way Laser SystemCandela Corpation · 2014
- 7 generations backK150326 PicoWay Laser SystemCandela Corporation · 2015
- 6 generations backK152012 EVO platformQuanta System Spa · 2015
- 5 generations backK160368 EVO platformQuanta System Spa · 2016
- 4 generations backK163222 Discovery Pico FamilyQuanta System Spa · 2016
- 3 generations backK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 2 generations backK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 1 generation backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
- This deviceK202503 ChromeQuanta System Spa · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation · 2022 · cites it directly7descendants
- K241527Pastelle ProWontech Co., Ltd. · 2025 · cites it directly3descendants
- K233473Deka LotusEl.En S.P.A. · 2024 · cites it directly1descendant
- K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K253765Vanish ProDdc Technologies, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −25 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −24 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −22 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −21 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −20 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −19 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −18 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −17 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −15 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −14 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −13 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −12 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −11 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −10 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −9 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −8 | K142372 | Pico Way Laser System | Candela Corpation | 2014 | — |
| −7 | K150326 | PicoWay Laser System | Candela Corporation | 2015 | — |
| −6 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| −5 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| −4 | K163222 | Discovery Pico Family | Quanta System Spa | 2016 | — |
| −3 | K171945 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| −2 | K172376 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| −1 | K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | Quanta System Spa | 2019 | — |
| 0 (this device) | K202503 | Chrome | Quanta System Spa | 2020 | — |
| +1 | K213569 | HOLLYWOOD SPECTRA Laser System | Lutronic Corporation | 2022 | — |
| +1 | K241527 | Pastelle Pro | Wontech Co., Ltd. | 2025 | — |
| +1 | K233473 | Deka Lotus | El.En S.P.A. | 2024 | — |
| +2 | K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026 | — |
| +1 | K253765 | Vanish Pro | Ddc Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 12 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 24 | 0 |
| 1998 | 15 | 0 |
| 1999 | 11 | 0 |
| 2000 | 26 | 0 |
| 2001 | 26 | 0 |
| 2002 | 35 | 0 |
| 2003 | 24 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 0 |
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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico DermSummary page 6…in dermatology. Regulation Number: 21 CFR 878.4810 Product Code: GEX Main Predicate Device Pico Platform (K191842), Quanta System SpA Reference Device Evo family (K160368), Quanta System SpA Performance Standards: There… | 2019 |
| † | K160368 | EVO platform | 2016 |
What descends from it? (12)
See all 128 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213569 | HOLLYWOOD SPECTRA Laser System | 2022 | 7 |
| K241527 | Pastelle Pro | 2025 | 3 |
| K233473 | Deka Lotus | 2024 | 1 |
| K253765 | Vanish Pro | 2026 | 0 |
| K250281 | Deka Lotus | 2025 | 0 |
| K240752 | Deka Toro | 2024 | 0 |
| K223404 | Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V | 2023 | 0 |
| K213726 | PL-1 Skin Treatment System | 2022 | 0 |
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 25 years and passes through 12 companies; a new generation was cleared every 9 months on median.
- 15 of the 298 ancestors have a recall of any class.
- Of its descendants, K213569 (Lutronic Corporation, 2022) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K191842.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
General intended use Chrome 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. Indications for use 1064 & 532 nm (Q-Switched, nanosecond mode) Chrome is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal…
Read the full statement (664 words)
General intended use
Chrome 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.
Indications for use
1064 & 532 nm (Q-Switched, nanosecond mode)
Chrome is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
Treatment of benign vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
- Cherry angioma
- Spider nevi
Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-Iait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
Treatment of seborrheic keratosis
Treatment of post inflammatory hyperpigmentation
Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
Removal of dark ink (black, blue and brown) tattoos
Removal of benign pigmented lesions including;
- nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
Treatment of common nevi
Removal or lightening of unwanted hair
Skin resurfacing procedures for the treatment of acne scars and wrinkles
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 benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments.
It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.
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 benign 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 (mild to moderate acne vulgaris).
Integrated Skin Cooler
The intended use of the integrated cooling system in the laser hand piece 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 fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202503: Chrome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202503
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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