510(k) · Cleared
ClearedJoule 810/940/980 Multi-Platform 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 Jun 19, 2013 as substantially equivalent to K112031 (Alma Lasers, Inc., 2011) and 4 other predicates after a 300-day review. Its family tree reaches back 19 generations to 1995. 6 later devices descend from it.
- Decided
- Jun 19, 2013
- Review
- 300 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 19 generations to K943450 (1995). 413 ancestors in all, the oldest K771218 (1978). 6 later devices descend from it, 3 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
- 2 generations backK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- 1 generation backK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- This deviceK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
- Descendant · cites it directly · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK251077 JOULE 1064nm System and AccessoriesSciton, Inc · 2025
- Descendant · 2 generations on · 0 of its ownK252063 Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK191349 980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK173067 LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC · 2018
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 backK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
- 2 generations backK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- 1 generation backK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- This deviceK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015 · cites it directly3descendants
- K251077JOULE 1064nm System and AccessoriesSciton, Inc · 2025 · cites it directly0descendants
- K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019 · 2 generations on0descendants
- K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC · 2018 · 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 | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810 | A.R.C Laser GmbH | 2008 | — |
| −2 | K091562 | Doctor Smile a-810 and B-980 Lasers | Lambda Scientific Spa | 2009 | — |
| −1 | K102036 | Doctor Surgery Diode Lasers Family | Lambda S.P.A. | 2010 | — |
| 0 (this device) | K122567 | Joule 810/940/980 Multi-Platform System | Sciton, Inc | 2013 | — |
| +1 | K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015 | — |
| +1 | K251077 | JOULE 1064nm System and Accessories | Sciton, Inc | 2025 | — |
| +2 | K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems… | Wuhan Dimed Laser Technology Co., Ltd. | 2025 | — |
| +2 | K191349 | 980nm Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | 2019 | — |
| +2 | K173067 | LightForce LTS Model 1000, 1500, 2500, and 4000 | Litecure, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 18 | 0 |
| 1995 | 18 | 0 |
| 1996 | 25 | 0 |
| 1997 | 30 | 0 |
| 1998 | 27 | 0 |
| 1999 | 22 | 0 |
| 2000 | 31 | 0 |
| 2001 | 34 | 0 |
| 2002 | 40 | 0 |
| 2003 | 34 | 0 |
| 2004 | 24 | 0 |
| 2005 | 16 | 0 |
| 2006 | 10 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Summary page 1…Regulatory Affairs June 17, 2013 JOULE 810/940/980 Multi-Platform System Laser Powered Surgical Device (and Accessories) Laser Surgical Instrument, 21 CFR 878.4810. K112031: Alma Lasers Modified Diode Laser Module K102036: LAMBDA S.p.A. Doctor Diode Laser Family K100558: Quanta System QUANTA Diode Las… | 2011 |
| * | K102036 | Doctor Surgery Diode Lasers FamilySummary page 1…/980 Multi-Platform System Laser Powered Surgical Device (and Accessories) Laser Surgical Instrument, 21 CFR 878.4810. K112031: Alma Lasers Modified Diode Laser Module K102036: LAMBDA S.p.A. Doctor Diode Laser Family K100558: Quanta System QUANTA Diode Laser Family K100143: CAOQ Group Pilot Diode Laser… | 2010 |
| * | K100558 | Quanta Diode Laser SystemSummary page 1…l Device (and Accessories) Laser Surgical Instrument, 21 CFR 878.4810. K112031: Alma Lasers Modified Diode Laser Module K102036: LAMBDA S.p.A. Doctor Diode Laser Family K100558: Quanta System QUANTA Diode Laser Family K100143: CAOQ Group Pilot Diode Laser K053628: Lumenis LightSheer Duet The JOULE 810/9… | 2010 |
| * | K100143 | Pilot Diode Laser, Model 002-00139Summary page 1…ent, 21 CFR 878.4810. K112031: Alma Lasers Modified Diode Laser Module K102036: LAMBDA S.p.A. Doctor Diode Laser Family K100558: Quanta System QUANTA Diode Laser Family K100143: CAOQ Group Pilot Diode Laser K053628: Lumenis LightSheer Duet The JOULE 810/940/980 Multi-Platform System consist of a console… | 2010 |
| * | K053628 | Lightsheer Duet Laser SystemSummary page 1…sers Modified Diode Laser Module K102036: LAMBDA S.p.A. Doctor Diode Laser Family K100558: Quanta System QUANTA Diode Laser Family K100143: CAOQ Group Pilot Diode Laser K053628: Lumenis LightSheer Duet The JOULE 810/940/980 Multi-Platform System consist of a console and laser deliver accessories. It uses… | 2006 |
What descends from it? (6)
3 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 18 years and passes through 9 companies; a new generation was cleared every 9 months on median.
- 19 of the 413 ancestors have a recall of any class.
- Of its descendants, K151890 (Wuhan Gigaa Optronics Technology Co., Ltd., 2015) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K112031.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 810/840/980 Multi-Platform System (and delivery accessaries used to deliver optical energy) is indicated for use in surgica) applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. The device is specifically indicated for use as follows: £10nm and 380nm Dermatology/Aesthetics: - Photocoagulation of vascular & dermatologicat lesions of the face and extremities -…
Read the full statement (603 words)
The JOULE 810/840/980 Multi-Platform System (and delivery accessaries used to deliver optical energy) is indicated for use in surgica) applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue.
The device is specifically indicated for use as follows:
£10nm and 380nm
Dermatology/Aesthetics:
- Photocoagulation of vascular & dermatologicat lesions of the face and extremities
- Photocoagulation of telangiectasia, veinutectasia of the legs and face
- Treatment of reticular veins and branch varicosities
- Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas
- Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous takes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epiderma! pigment lesions as ientigines. Epidermal nevi, spider nevi.
- Demmatological surgery: Condytoma acuminate, warts, small non malignant skon tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment.
- Seborrheic keratosis
- Mixoid cyst
- Papillary varix
- Acne treatment
- Hair removal of unwanted hair from skin type |-V
Plastic Surgery:
- Cut, coagulation & vaporization
- Resurfacing
- Blepharoplasty
Vascular Surgery:
- Endoluminal or endovenous laser surgery for saphenous incompetent veins
810nm
Temporary refief of minor muscie and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means ot topical elevated tissue temperature from infrared spectral emissions.
The JOULE Multi-Piatform System is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telanglectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. it is also indicated for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins. Permanent hair reduction is defined as the long-temm, stable reduction in the number of hairs regrowing when measured at §, 9, and 12 months after the completion of a treatment regime.
240nm
The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment {including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coaguiation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment andfor removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
280nm
The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) is indicated for use in inciston, excision, vaporization, ablation, hemostasis or coagulation of soft tissue endovenous occlusion of the greater saphenous vein. The JOULE 980 System is further indicated for laser assisted Gpolysis.
The device is specifically indicated for use as follows!
Dermatology, Plastic Surgery and Podiatry:
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, skin, fat or muscle tissue and dermabrasion. Examples include:
- Matrixectomy
- Excision of neuromas
- Excision of periungual and subungual wars
- Excision of plantar warts
- Excision of keioids
- Excision of cutaneous lesions
- Dermabrasion
- Vaporization and hemostasis of capillary hemangioma
- Debridement of wounds
- Photocoagutation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and extremities
- Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux,
- Treatment of reticular veins and branch varicosities
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux:
Indicated for use with their delivery accessories in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
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/K122567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122567: Joule 810/940/980 Multi-Platform System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122567
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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