510(k) · Cleared
ClearedGenesisplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cutera, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 15, 2013 as substantially equivalent to K103626 (Cutera, Inc., 2011) after a 272-day review. Its family tree reaches back 9 generations to 1994. 18 later devices descend from it.
- Decided
- May 15, 2013
- Review
- 272 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K936109 (1994). 111 ancestors in all, the oldest K820106 (1982). 18 later devices descend from it, 3 citing it directly.
- 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 deviceK122493 GenesisplusCutera, Inc. · 2013
- Descendant · cites it directly · 10 of its ownK140122 Candela Gentlemax Family of Laser SystemCandela Corp. · 2014
- Descendant · cites it directly · 5 of its ownK150907 Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S · 2015
- Descendant · 2 generations on · 4 of its ownK161162 Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius…Ellipse A/S · 2016
- Descendant · 2 generations on · 3 of its ownK201111 GentleMax Pro PlusCandela Corporation · 2020
- Descendant · 2 generations on · 2 of its ownK192856 MT OneM&T S.R.L. · 2020
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 deviceK122493 GenesisplusCutera, Inc. · 2013
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K140122Candela Gentlemax Family of Laser SystemCandela Corp. · 2014 · cites it directly10descendants
- K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S · 2015 · cites it directly5descendants
- K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S · 2016 · 2 generations on4descendants
- K201111GentleMax Pro PlusCandela Corporation · 2020 · 2 generations on3descendants
- K192856MT OneM&T S.R.L. · 2020 · 2 generations on2descendants
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) | K122493 | Genesisplus | Cutera, Inc. | 2013 | — |
| +1 | K140122 | Candela Gentlemax Family of Laser System | Candela Corp. | 2014 | — |
| +1 | K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse… | Ellipse A/S | 2015 | — |
| +2 | K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse… | Ellipse A/S | 2016 | — |
| +2 | K201111 | GentleMax Pro Plus | Candela Corporation | 2020 | — |
| +2 | K192856 | MT One | M&T S.R.L. | 2020 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (1)
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…Name: Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48 Legally Marketed Predicate Cutera GenesisPlus under K103626 Device: Description of the Cutera The Cutera GenesisPlus Laser unit and controls are GenesisPlus Laser: co… | 2011 |
What descends from it? (18)
See all 183 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 19 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 111 ancestors have a recall of any class.
- Of its descendants, K140122 (Candela Corp., 2014) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K103626.
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 Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopiclaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications. Dermatology: The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign…
Read the full statement (173 words)
The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopiclaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications.
Dermatology:
The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloid scars), and warts.
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-VI), including tanned skin.
PodilatrV:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
* Matrixectomy
* Periungual and subungual warts
* Plantar warts
* Radical nail excision
* Neuromas
The Cuterat 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. etc.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122493: Genesisplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122493
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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