510(k) · Cleared
ClearedJoule Clearsense Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sciton, Inc · PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Cleared on Dec 7, 2011 as substantially equivalent to K103626 (Cutera, Inc., 2011) and 2 other predicates after a 190-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Dec 7, 2011
- Review
- 190 days
- Class
- Class II
- Product code
- PDZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K936109 (1994). 112 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations between
- 3 generations backK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
- 2 generations backK093545 Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010
- 1 generation backK103626 Cutera Genesisplus Laser SystemCutera, Inc. · 2011
- This deviceK111483 Joule Clearsense Laser SystemSciton, Inc · 2011
Show all 9 generations
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 7 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 6 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 5 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 4 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 3 generations backK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
- 2 generations backK093545 Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010
- 1 generation backK103626 Cutera Genesisplus Laser SystemCutera, Inc. · 2011
- This deviceK111483 Joule Clearsense Laser SystemSciton, Inc · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −8 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −6 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −5 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −4 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −3 | K083215 | Incisive Family of Inpulse ND:Yag Lasers | Incisive, LLC | 2009 | — |
| −2 | K093545 | Pinpointe Footlaser Model 6W, 30W, 100W | Incisive, Inc. (Formerly Named Incisive, LLC) | 2010 | — |
| −1 | K103626 | Cutera Genesisplus Laser System | Cutera, Inc. | 2011 | — |
| 0 (this device) | K111483 | Joule Clearsense Laser System | Sciton, Inc | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 11 | 0 |
| 1995 | 8 | 0 |
| 1996 | 10 | 0 |
| 1997 | 11 | 0 |
| 1998 | 10 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 PDZ? 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 PDZ device
- #1 K253960 Medicell Mycosis Laser (MCML24004)score 11.3 · 2 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 |
|---|---|---|---|
| * | K103626 | Cutera Genesisplus Laser SystemSummary page 1…er: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class !l Product Code: GEX K103626: Cutera GenesisPlus Laser System K093547: PinPointe FootLaser K093545: PinPointe FootLaser The JOULE ClearSense Laser System is… | 2011 |
| * | K093547 | Pinpointe FootlaserSummary page 1…er surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class !l Product Code: GEX K103626: Cutera GenesisPlus Laser System K093547: PinPointe FootLaser K093545: PinPointe FootLaser The JOULE ClearSense Laser System is a transportable medical device used for t… | 2010 |
| * | K093545 | Pinpointe Footlaser Model 6W, 30W, 100WSummary page 1…e in general and plastic surgery and in dermatology Regulatory Class: Class !l Product Code: GEX K103626: Cutera GenesisPlus Laser System K093547: PinPointe FootLaser K093545: PinPointe FootLaser The JOULE ClearSense Laser System is a transportable medical device used for the treatment of temporary inc… | 2010 |
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 17 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 112 ancestors have a recall of any class.
- 6 other devices also cite its predicate K103626.
How does its category compare?
All PDZ devicesPDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · PDZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PDZ
196in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDZ
No recall names PDZ since 2007.
Adverse event reports per year · PDZ
1in 2019
MAUDE reports naming product code PDZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 205 | 0 | 0 |
| 2012 | 6 | 196 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The JOULE ClearSense Laser System is indicated for ablation, vaporization, incision, excision and coagulation of soft tissue, including:
Matrixectomy
Periungual and subengual warts
Planter warts
Radical nail excision
Neuromas
It is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T, menlagrophytes, and/or yeasts Candida albicans, etc.).
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/K111483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111483: Joule Clearsense Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111483
Report an extraction error
Are you the manufacturer?
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