510(k) · Cleared
ClearedJoule System
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 Jan 29, 2018 as substantially equivalent to K101916 (Sciton, Inc, 2011) and 4 other predicates after a 105-day review. Its family tree reaches back 19 generations to 1995. 5 later devices descend from it.
- Decided
- Jan 29, 2018
- Review
- 105 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 19 generations to K943450 (1995). 510 ancestors in all, the oldest K771218 (1978). 5 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 2 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 1 generation backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- This deviceK173285 Joule SystemSciton, Inc · 2018
- Descendant · cites it directly · 3 of its ownK180508 Joule SystemSciton, Inc · 2018
- Descendant · cites it directly · 1 of its ownK233803 UltraClear Laser System (N/A)Acclaro Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK253245 Boston 2910 (Boston 2910)Boston Aesthetics, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251699 The Botticelli (Model: Athena)Bellamia Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK210847 UltraClear Fractional Laser SystemFa International, LP · 2021
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 6 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 5 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 2 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 1 generation backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- This deviceK173285 Joule SystemSciton, Inc · 2018
Most influential descendants
Showing 5 of 5 · See all- K180508Joule SystemSciton, Inc · 2018 · cites it directly3descendants
- K233803UltraClear Laser System (N/A)Acclaro Corporation · 2024 · cites it directly1descendant
- K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc. · 2026 · 2 generations on0descendants
- K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc. · 2025 · 2 generations on0descendants
- K210847UltraClear Fractional Laser SystemFa International, LP · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −6 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −5 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −2 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −1 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| 0 (this device) | K173285 | Joule System | Sciton, Inc | 2018 | — |
| +1 | K180508 | Joule System | Sciton, Inc | 2018 | — |
| +1 | K233803 | UltraClear Laser System (N/A) | Acclaro Corporation | 2024 | — |
| +2 | K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | 2026 | — |
| +2 | K251699 | The Botticelli (Model: Athena) | Bellamia Technologies, Inc. | 2025 | — |
| +2 | K210847 | UltraClear Fractional Laser System | Fa International, LP | 2021 | — |
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 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 7 | 0 |
| 1991 | 10 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 25 | 0 |
| 1995 | 27 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 31 | 0 |
| 1999 | 26 | 0 |
| 2000 | 34 | 0 |
| 2001 | 32 | 0 |
| 2002 | 40 | 0 |
| 2003 | 46 | 0 |
| 2004 | 32 | 0 |
| 2005 | 26 | 0 |
| 2006 | 16 | 0 |
| 2007 | 17 | 0 |
| 2008 | 16 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | K101916 | Joule Multi-Platform SystemSummary page 4…Laser Powered Surgical Device (and Accessories) Classification Name: Laser Surgical Instrument, 21 CFR 878.4810. Product Code: GEX Legally Marketed K101916: Joule Multi-Platform System Predicate Device: K081352: Profile Multi-Platform System K100270: Artisa… | 2011 |
| * | K081352 | Profile Multi-Platform SystemSummary page 4…ation Name: Laser Surgical Instrument, 21 CFR 878.4810. Product Code: GEX Legally Marketed K101916: Joule Multi-Platform System Predicate Device: K081352: Profile Multi-Platform System K100270: Artisan Aesthetic System K110907: Palomar I… | 2008 |
| * | K100270 | Artisan Aesthetic SystemSummary page 4…duct Code: GEX Legally Marketed K101916: Joule Multi-Platform System Predicate Device: K081352: Profile Multi-Platform System K100270: Artisan Aesthetic System K110907: Palomar Icon Aesthetic System K142376: Palomar I… | 2010 |
| * | K110907 | Palomar Icon (TM) Aesthetic SystemSummary page 4…Joule Multi-Platform System Predicate Device: K081352: Profile Multi-Platform System K100270: Artisan Aesthetic System K110907: Palomar Icon Aesthetic System K142376: Palomar Icon Aesthetic System Description of The JOULE Pr… | 2011 |
| * | K142376 | Palomar Icon Aesthetic SystemSummary page 4…ofile Multi-Platform System K100270: Artisan Aesthetic System K110907: Palomar Icon Aesthetic System K142376: Palomar Icon Aesthetic System Description of The JOULE ProFractional System consists of a console and laser deliver JOU… | 2014 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 25 of the 510 ancestors have a recall of any class.
- Of its descendants, K180508 (Sciton, Inc, 2018) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K101916.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Joule 2940 nm ProFractional System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173285: Joule System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173285
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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