510(k) · Cleared
ClearedPicoSure Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 17, 2016 as substantially equivalent to K143105 (Cynosure, Inc., 2015) and 1 other predicate after an 85-day review. Its family tree reaches back 21 generations to 1995. 20 later devices descend from it.
- Decided
- May 17, 2016
- Review
- 85 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K943450 (1995). 275 ancestors in all, the oldest K800617 (1980). 20 later devices descend from it, 3 citing it directly.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK133364 Picosure WorkstationCynosure, Inc. · 2014
- 2 generations backK140719 Picosure WorkstationCynosure, Inc. · 2014
- 1 generation backK143105 Picosure WorkstationCynosure, Inc. · 2015
- This deviceK160480 PicoSure WorkstationCynosure, Inc. · 2016
- Descendant · cites it directly · 9 of its ownK173199 PicoSure WorkstationCynosure, Inc. · 2018
- Descendant · cites it directly · 9 of its ownK172077 Cutera enlighten III Laser SystemCutera, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK173700 PICOPLUS Laser SystemLutronic Corporation · 2018
- Descendant · 3 generations on · 6 of its ownK200116 PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 3 of its ownK210226 PicoSure WorkstationCynosure, LLC · 2021
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 8 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 7 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 6 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 5 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 4 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 3 generations backK133364 Picosure WorkstationCynosure, Inc. · 2014
- 2 generations backK140719 Picosure WorkstationCynosure, Inc. · 2014
- 1 generation backK143105 Picosure WorkstationCynosure, Inc. · 2015
- This deviceK160480 PicoSure WorkstationCynosure, Inc. · 2016
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K173199PicoSure WorkstationCynosure, Inc. · 2018 · cites it directly9descendants
- K172077Cutera enlighten III Laser SystemCutera, Inc. · 2017 · cites it directly9descendants
- K173700PICOPLUS Laser SystemLutronic Corporation · 2018 · 2 generations on7descendants
- K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd. · 2020 · 3 generations on6descendants
- K210226PicoSure WorkstationCynosure, LLC · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −8 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −7 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −6 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −5 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −4 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −3 | K133364 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −2 | K140719 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −1 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| 0 (this device) | K160480 | PicoSure Workstation | Cynosure, Inc. | 2016 | — |
| +1 | K173199 | PicoSure Workstation | Cynosure, Inc. | 2018 | — |
| +1 | K172077 | Cutera enlighten III Laser System | Cutera, Inc. | 2017 | — |
| +2 | K173700 | PICOPLUS Laser System | Lutronic Corporation | 2018 | — |
| +3 | K200116 | PicoSecond Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| +2 | K210226 | PicoSure Workstation | Cynosure, LLC | 2021 | — |
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 | 24 | 0 |
| 2001 | 24 | 0 |
| 2002 | 33 | 0 |
| 2003 | 23 | 0 |
| 2004 | 17 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K143105 | Picosure WorkstationSummary page 4…t Code(s) GEX 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed PicoSure Workstation K143105 RevLite Q-Switched Nd:YAG Laser System K133254 807.92(a)(4) Device Description… | 2015 |
| * | K133254 | Revlite Q-Switched ND:Yag Laser SystemSummary page 4…equivalence is claimed PicoSure Workstation K143105 RevLite Q-Switched Nd:YAG Laser System K133254 807.92(a)(4) Device Description The PicoSure™ workstation is a high-powered, Alexandrite… | 2014 |
What descends from it? (20)
See all 203 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 21 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 10 of the 275 ancestors have a recall of any class.
- Of its descendants, K173199 (Cynosure, Inc., 2018) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K143105.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
755 nm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with
the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin
Types I - IV.
532 nm:
The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I - III.
1064 nm:
The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160480: PicoSure Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160480
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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