510(k) · Cleared
ClearedCutera Qswitch Laser System
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 Jun 22, 2011 as substantially equivalent to K083899 (Hoya Conbio, Inc., 2009) after a 260-day review. Its family tree reaches back 16 generations to 1995. 49 later devices descend from it.
- Decided
- Jun 22, 2011
- Review
- 260 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K943450 (1995). 249 ancestors in all, the oldest K800617 (1980). 49 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 2 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 1 generation backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- This deviceK102954 Cutera Qswitch Laser SystemCutera, Inc. · 2011
- Descendant · cites it directly · 47 of its ownK140727 Cutera Picosecond Laser SystemCutera, Inc. · 2014
- Descendant · 2 generations on · 41 of its ownK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- Descendant · 3 generations on · 34 of its ownK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
- Descendant · 3 generations on · 33 of its ownK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
- Descendant · 3 generations on · 32 of its ownK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 3 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 2 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 1 generation backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- This deviceK102954 Cutera Qswitch Laser SystemCutera, Inc. · 2011
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K140727Cutera Picosecond Laser SystemCutera, Inc. · 2014 · cites it directly47descendants
- K153527PicoWay Laser SystemSyneron Candela Corporation · 2016 · 2 generations on41descendants
- K160607PicoWay Laser SystemSyneron Candela Corporation · 2016 · 3 generations on34descendants
- K162454PicoWay Laser SystemSyneron Candela Corporation · 2017 · 3 generations on33descendants
- K170597PicoWay Laser SystemSyneron Candela Corporation · 2017 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −3 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −1 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| 0 (this device) | K102954 | Cutera Qswitch Laser System | Cutera, Inc. | 2011 | — |
| +1 | K140727 | Cutera Picosecond Laser System | Cutera, Inc. | 2014 | — |
| +2 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| +3 | K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| +3 | K162454 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| +3 | K170597 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 22 | 0 |
| 1998 | 15 | 0 |
| 1999 | 9 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 31 | 0 |
| 2003 | 22 | 0 |
| 2004 | 13 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K083899 | Revlite Q-Switched ND:Yag Laser SystemSummary page 1…79-GEX, 21 CIFR 878-48 Legally Marketed Predicate RevLite Q-Switched Nd:YAG Laser System Device: K083899 Description of the Cutera The Cutera QSwitch Laser unit and controls are contained QSwitch Laser System:… | 2009 |
What descends from it? (49)
See all 492 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 16 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 9 of the 249 ancestors have a recall of any class.
- Of its descendants, K140727 (Cutera, Inc., 2014) has gone furthest, with 47 descendants of its own.
- 4 other devices also cite its predicate K083899.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Indications for Use: 1064 nm wavelength * Tattoo Removal (dark ink: blue and black) * Nevus of Ota * Removal or lightening of hair with or without adjuvant preparation. * Skin Resurfacing for Acne Scars and Wrinkles * Benign cutaneous lesions, such as, but not limited to: striae and…
Read the full statement (180 words)
Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Indications for Use:
1064 nm wavelength
* Tattoo Removal (dark ink: blue and black)
* Nevus of Ota
* Removal or lightening of hair with or without adjuvant preparation.
* Skin Resurfacing for Acne Scars and Wrinkles
* Benign cutaneous lesions, such as, but not limited to: striae and scars
* Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar
532 nm wavelength
* Tattoo removal (light ink: red, sky blue, green)
* Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
* Epiderrmal Pigmented lesions including but not limited to: cafe-au-Iait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
* Skin Resurfacing for Acne Scars and Wrinkles
* Benign cutaneous lesions, such as, but not limited to: striae and scars
* Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102954: Cutera Qswitch 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/K102954
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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