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 Jul 22, 2014 as substantially equivalent to K121346 (Cynosure, Inc., 2012) and 1 other predicate after a 263-day review. Its family tree reaches back 18 generations to 1995. 51 later devices descend from it.
- Decided
- Jul 22, 2014
- Review
- 263 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K943450 (1995). 252 ancestors in all, the oldest K800617 (1980). 51 later devices descend from it, 5 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 deviceK133364 Picosure WorkstationCynosure, Inc. · 2014
- Descendant · cites it directly · 50 of its ownK140719 Picosure WorkstationCynosure, Inc. · 2014
- Descendant · 2 generations on · 49 of its ownK143105 Picosure WorkstationCynosure, Inc. · 2015
- Descendant · cites it directly · 41 of its ownK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- Descendant · cites it directly · 34 of its ownK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
- Descendant · cites it directly · 33 of its ownK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
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 deviceK133364 Picosure WorkstationCynosure, Inc. · 2014
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K140719Picosure WorkstationCynosure, Inc. · 2014 · cites it directly50descendants
- K143105Picosure WorkstationCynosure, Inc. · 2015 · 2 generations on49descendants
- K153527PicoWay Laser SystemSyneron Candela Corporation · 2016 · cites it directly41descendants
- K160607PicoWay Laser SystemSyneron Candela Corporation · 2016 · cites it directly34descendants
- K162454PicoWay Laser SystemSyneron Candela Corporation · 2017 · cites it directly33descendants
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) | K133364 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| +1 | K140719 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| +2 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| +1 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| +1 | K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| +1 | K162454 | 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 | 10 | 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 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K121346 | Picosure WorkstationSummary page 3…fairs 1-781-993-2414 choy@cynosure, com April 4, 2016 PicoSure™ workstation Laser Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48 PicoSure™ workstation (K)121346 Hoya ConBio RevLite (K)103118 The PicoSure™ workstation is a high-powered, Q-switched Alexandrite system that delivers laser ene… | 2012 |
| * | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorSummary page 3…osure, com April 4, 2016 PicoSure™ workstation Laser Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48 PicoSure™ workstation (K)121346 Hoya ConBio RevLite (K)103118 The PicoSure™ workstation is a high-powered, Q-switched Alexandrite system that delivers laser energy in the 755-nm wavelength.… | 2010 |
What descends from it? (51)
See all 515 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 9 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 252 ancestors have a recall of any class.
- Of its descendants, K140719 (Cynosure, Inc., 2014) has gone furthest, with 50 descendants of its own.
- 11 other devices also cite its predicate K121346.
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 PicoSure™ workstation is indicated for tattoo and benign pigmented lesion removal.
The PicoSure™ workstation operating with the 3mm or 6mm handpiee and the FOCUS lens array is indicated for the treatment of acne scars in Fitzpatrick skin types I-IV.
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/K133364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133364: Picosure Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133364
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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