510(k) · Cleared
ClearedmJOULE System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sciton, Inc · GEX Powered Laser Surgical Instrument
Cleared on Apr 15, 2022 as substantially equivalent to K191842 (Quanta System Spa, 2019) and 2 other predicates after a 189-day review. Its family tree reaches back 26 generations to 1995.
- Decided
- Apr 15, 2022
- Review
- 189 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 26 generations to K943450 (1995). 569 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- 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 deviceK213350 mJOULE System and AccessoriesSciton, Inc · 2022
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 deviceK213350 mJOULE System and AccessoriesSciton, Inc · 2022
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) | K213350 | mJOULE System and Accessories | Sciton, Inc | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 9 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 28 | 0 |
| 1995 | 26 | 0 |
| 1996 | 30 | 0 |
| 1997 | 32 | 0 |
| 1998 | 33 | 0 |
| 1999 | 30 | 0 |
| 2000 | 36 | 0 |
| 2001 | 35 | 0 |
| 2002 | 44 | 0 |
| 2003 | 48 | 0 |
| 2004 | 35 | 0 |
| 2005 | 27 | 0 |
| 2006 | 19 | 0 |
| 2007 | 19 | 0 |
| 2008 | 20 | 0 |
| 2009 | 11 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 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? (3)
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 5…red Surgical Device (and Accessories) Classification Name: Laser Surgical Instrument, 21 CFR 878.4810. Classification Product GEX Code: Legally Marketed K191842 Quanta System Discovery Pico Family Predicate Device: K182088 Fotona Dynamis Pro Family K023881 S… | 2019 |
| * | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroSummary page 5…Surgical Instrument, 21 CFR 878.4810. Classification Product GEX Code: Legally Marketed K191842 Quanta System Discovery Pico Family Predicate Device: K182088 Fotona Dynamis Pro Family K023881 Sciton Profile 1064 Laser System and Accessories Description of the… | 2018 |
| * | K023881 | Profile 1064 Laser SystemSummary page 5…uct GEX Code: Legally Marketed K191842 Quanta System Discovery Pico Family Predicate Device: K182088 Fotona Dynamis Pro Family K023881 Sciton Profile 1064 Laser System and Accessories Description of the The mJOULE 1064nm Laser System consists of a console and l… | 2003 |
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 27 years and passes through 13 companies; a new generation was cleared every 9 months on median.
- 30 of the 569 ancestors have a recall of any class.
- 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. 2022, 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?
The mJoule 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port…
Read the full statement (322 words)
The mJoule 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The lasers are 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.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The mJoule 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-V1), including tanned skin.
The mJoule 1064 laser system and accessories is indicated for the treatment of facial wrinkles.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
Treatment of Aphthous Ulcers.
Excision and Vaporization of Herpes Simplex I and II.
Laser assisted uvulopalatoplasty (LAUP).
Laser assisted lipolysis.
Treatment of mild to moderate inflammatory acne vulgaris.
Surgical Applications:
Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213350 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213350: mJOULE System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213350
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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