510(k) · Cleared
ClearedCutera Genesisplus Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cutera, Inc. · PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Cleared on Apr 5, 2011 as substantially equivalent to K022226 (Altus Medical, Inc., 2002) and 1 other predicate after a 116-day review. Its family tree reaches back 8 generations to 1994. 121 later devices descend from it.
- Decided
- Apr 5, 2011
- Review
- 116 days
- Class
- Class II
- Product code
- PDZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K936109 (1994). 110 ancestors in all, the oldest K820106 (1982). 121 later devices descend from it, 7 citing it directly.
- Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 5 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 4 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 3 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 2 generations backK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
- 1 generation backK093545 Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010
- This deviceK103626 Cutera Genesisplus Laser SystemCutera, Inc. · 2011
- Descendant · cites it directly · 65 of its ownK113702 Fotona XP ND: Yag Laser SystemFotona D.D. · 2012
- Descendant · 2 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · cites it directly · 34 of its ownK113810 Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc. · 2012
- Descendant · 2 generations on · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · cites it directly · 33 of its ownK120235 Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag…Aerolase Medical Lasers, LLC · 2012
Showing 5 of 121 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 121 · See all- K113702Fotona XP ND: Yag Laser SystemFotona D.D. · 2012 · cites it directly65descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 2 generations on62descendants
- K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc. · 2012 · cites it directly34descendants
- K133837Viora V-TotalViora, Ltd. · 2014 · 2 generations on33descendants
- K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC · 2012 · cites it directly33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −7 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −5 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −4 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −3 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −2 | K083215 | Incisive Family of Inpulse ND:Yag Lasers | Incisive, LLC | 2009 | — |
| −1 | K093545 | Pinpointe Footlaser Model 6W, 30W, 100W | Incisive, Inc. (Formerly Named Incisive, LLC) | 2010 | — |
| 0 (this device) | K103626 | Cutera Genesisplus Laser System | Cutera, Inc. | 2011 | — |
| +1 | K113702 | Fotona XP ND: Yag Laser System | Fotona D.D. | 2012 | — |
| +2 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +1 | K113810 | Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules | Alma Lasers, Inc. | 2012 | — |
| +2 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +1 | K120235 | Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers… | Aerolase Medical Lasers, LLC | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 8 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 6 | 0 |
| 2022 | 12 | 0 |
| 2023 | 10 | 0 |
| 2024 | 13 | 0 |
| 2025 | 19 | 0 |
| 2026 | 13 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Summary page 1…92 - fax [email protected] November 24, 201b Cutera GenesisPlus Laser System Nd:YAG Laser Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48 Cutera Nd:YAG Laser K022226 PinPointe Footlaser K09354 and K093545 The Cutera GenesisPlus Laser unit and controls are contained in a single console. Electri… | 2002 |
| Kept off the family tree | K083545 | FDA’s K083545 is Ziehm Vision RFD Our OCR of the scanned summary read K083545, FDA’s number for Ziehm Vision RFD (Ziehm Imaging, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PinPointe Footlaser”. Kept off the family tree. Summary page 3…ry Cutera GenesisPlus Laser System 'Featunes s § s '9‘_,-_‘?' Ciitera; GeneslsPliisr"‘ ?PlnPolnte Footlases | CuteraiNd YI}Q j.aser et N %%ggi"”‘ “iaser BEOT I 1K09354,K083545} "1 M gxo B st S BN Wavelength 1064nm Nd:YAG 1064nm Nd:-YAG 1064nm Nd YAG Alming Beam 630-680nm 630-680nm none (€ 2.5mW) (s 2.5… | 2009 |
| * | K093545 | Pinpointe Footlaser Model 6W, 30W, 100WSummary page 1…201b Cutera GenesisPlus Laser System Nd:YAG Laser Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48 Cutera Nd:YAG Laser K022226 PinPointe Footlaser K09354 and K093545 The Cutera GenesisPlus Laser unit and controls are contained in a single console. Electrical power is supplied to the console by… | 2010 |
What descends from it? (121)
See all 1217 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113702 | Fotona XP ND: Yag Laser System | 2012 | 65 |
| K113810 | Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules | 2012 | 34 |
| K120235 | Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo… | 2012 | 33 |
| K122493 | Genesisplus | 2013 | 18 |
| K121508 | Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N | 2012 | 1 |
| K113843 | Freedom ND: Yag Laser System | 2012 | 0 |
| K111483 | Joule Clearsense Laser System | 2011 | 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 17 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 110 ancestors have a recall of any class.
- Of its descendants, K113702 (Fotona D.D., 2012) has gone furthest, with 65 descendants of its own.
- 10 other devices also cite its predicate K022226.
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 Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of genera! and plastic surgery, dermatology, endoscopic.laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary.thoracic surgery, podiatry and urology for surgical and aesthetic applications. Dermatoloqgy: The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign…
Read the full statement (186 words)
The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of genera! and plastic surgery, dermatology, endoscopic.laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary.thoracic surgery, podiatry and urology for surgical and aesthetic applications.
Dermatoloqgy:
The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte,, and treatment of benign cutaneous lesions, such as warts, scars and straie. The laser is also intended for the treatment of benign pigmented lesions.
The Cutera GenesisPlus laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The GenesisPlus laser is indicated for use on all skin types (Fitzpatrick I-V1), including tanned skin.
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
* Matrixectomy
* Periungual and subungual warts
o Plantar warts
* Radical nail excision
e Neuromas
The Cutera GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, efc.).
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/K103626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103626: Cutera Genesisplus 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/K103626
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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