510(k) · Cleared
ClearedCutera Picosecond 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 Aug 11, 2014 as substantially equivalent to K102954 (Cutera, Inc., 2011) and 2 other predicates after a 231-day review. Its family tree reaches back 18 generations to 1995. 14 later devices descend from it.
- Decided
- Aug 11, 2014
- Review
- 231 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K943450 (1995). 256 ancestors in all, the oldest K800617 (1980). 14 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 2 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 1 generation backK121346 Picosure WorkstationCynosure, Inc. · 2012
- This deviceK133945 Cutera Picosecond Laser SystemCutera, Inc. · 2014
- Descendant · cites it directly · 13 of its ownK160488 Cutera enlighten III Laser SystemCutera, Inc. · 2016
- Descendant · 2 generations on · 10 of its ownK170936 Cutera enlighten III Laser SystemCutera, Inc. · 2017
- Descendant · 3 generations on · 9 of its ownK172077 Cutera enlighten III Laser SystemCutera, Inc. · 2017
- Descendant · 4 generations on · 7 of its ownK173700 PICOPLUS Laser SystemLutronic Corporation · 2018
- Descendant · 5 generations on · 6 of its ownK200116 PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 5 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 4 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 3 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 2 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 1 generation backK121346 Picosure WorkstationCynosure, Inc. · 2012
- This deviceK133945 Cutera Picosecond Laser SystemCutera, Inc. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K160488Cutera enlighten III Laser SystemCutera, Inc. · 2016 · cites it directly13descendants
- K170936Cutera enlighten III Laser SystemCutera, Inc. · 2017 · 2 generations on10descendants
- K172077Cutera enlighten III Laser SystemCutera, Inc. · 2017 · 3 generations on9descendants
- K173700PICOPLUS Laser SystemLutronic Corporation · 2018 · 4 generations on7descendants
- K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd. · 2020 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −5 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −4 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −2 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −1 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| 0 (this device) | K133945 | Cutera Picosecond Laser System | Cutera, Inc. | 2014 | — |
| +1 | K160488 | Cutera enlighten III Laser System | Cutera, Inc. | 2016 | — |
| +2 | K170936 | Cutera enlighten III Laser System | Cutera, Inc. | 2017 | — |
| +3 | K172077 | Cutera enlighten III Laser System | Cutera, Inc. | 2017 | — |
| +4 | K173700 | PICOPLUS Laser System | Lutronic Corporation | 2018 | — |
| +5 | K200116 | PicoSecond Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
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 | 10 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 31 | 0 |
| 2003 | 22 | 0 |
| 2004 | 13 | 0 |
| 2005 | 9 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K102954 | Cutera Qswitch Laser SystemSummary page 4…aser Classification Name: Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878.4810 Legally Marketed Cutera Q-Switch Laser System (K102954) Predicate Devices: Quanta System Q-Plus T (K073549) Cynosure PicoSure (K121346) Device Description… | 2011 |
| * | K073549 | Q-Plus TSummary page 4…ed, laser 79-GEX, 21 CFR 878.4810 Legally Marketed Cutera Q-Switch Laser System (K102954) Predicate Devices: Quanta System Q-Plus T (K073549) Cynosure PicoSure (K121346) Device Description: The enlighten laser system is a multi-wavelength, p… | 2008 |
| * | K121346 | Picosure WorkstationSummary page 4….4810 Legally Marketed Cutera Q-Switch Laser System (K102954) Predicate Devices: Quanta System Q-Plus T (K073549) Cynosure PicoSure (K121346) Device Description: The enlighten laser system is a multi-wavelength, pulsed laser system designed… | 2012 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160488 | Cutera enlighten III Laser System | 2016 | 13 |
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 10 companies; a new generation was cleared every 1.0 years on median.
- 11 of the 256 ancestors have a recall of any class.
- Of its descendants, K160488 (Cutera, Inc., 2016) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K102954.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 enlighten laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
532 nm
The 532 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.
1064 nm
The 1064 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133945: Cutera Picosecond 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/K133945
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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