510(k) · Cleared
ClearedPicoWay Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candela Corporation · GEX Powered Laser Surgical Instrument
Cleared on Apr 16, 2015 as substantially equivalent to K121346 (Cynosure, Inc., 2012) and 1 other predicate after a 66-day review. Its family tree reaches back 19 generations to 1995. 68 later devices descend from it.
- Decided
- Apr 16, 2015
- Review
- 66 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K943450 (1995). 253 ancestors in all, the oldest K800617 (1980). 68 later devices descend from it, 6 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 2 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 1 generation backK142372 Pico Way Laser SystemCandela Corpation · 2014
- This deviceK150326 PicoWay Laser SystemCandela Corporation · 2015
- Descendant · cites it directly · 41 of its ownK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- Descendant · cites it directly · 37 of its ownK152012 EVO platformQuanta System Spa · 2015
- Descendant · cites it directly · 36 of its ownK160368 EVO platformQuanta System Spa · 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 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 6 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 5 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 4 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 3 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 2 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 1 generation backK142372 Pico Way Laser SystemCandela Corpation · 2014
- This deviceK150326 PicoWay Laser SystemCandela Corporation · 2015
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K153527PicoWay Laser SystemSyneron Candela Corporation · 2016 · cites it directly41descendants
- K152012EVO platformQuanta System Spa · 2015 · cites it directly37descendants
- K160368EVO platformQuanta System Spa · 2016 · cites it directly36descendants
- 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 |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −6 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −5 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −4 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −3 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −2 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −1 | K142372 | Pico Way Laser System | Candela Corpation | 2014 | — |
| 0 (this device) | K150326 | PicoWay Laser System | Candela Corporation | 2015 | — |
| +1 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| +1 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| +1 | K160368 | EVO platform | Quanta System Spa | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 3 | 0 |
| 2024 | 10 | 0 |
| 2025 | 13 | 0 |
| 2026 | 8 | 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 4…dermatology (21 CFR 878.4810) Product Code GEX Predicate and Reference Devices: Predicate Devices: Cynosure PicoSure™ workstation (K121346) (Primary Predicate) PicoWay Laser System (K142372) Reference devices: Syneron Medical Ltd.’s Transcend Sy… | 2012 |
| * | K142372 | Pico Way Laser SystemSummary page 4…t Code GEX Predicate and Reference Devices: Predicate Devices: Cynosure PicoSure™ workstation (K121346) (Primary Predicate) PicoWay Laser System (K142372) Reference devices: Syneron Medical Ltd.’s Transcend System (K120510); Candela Corporation’s GentleMAX Pro… | 2014 |
| † | K120510 | Transcend | 2013 |
| † | K133283 | Candela Gentlemax Family of Laser Systems | 2013 |
| † | K103539 | Quanta System Duolite | 2011 |
| † | K081324 | Candela Family of Q-Switched Alexandrite Lasers | 2008 |
| † | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | 2010 |
| † | K133254 | Revlite Q-Switched ND:Yag Laser System | 2014 |
| † | K132185 | Family of Coolglide Aesthetic Lasers | 2013 |
| † | K083889 | Fotona QX ND:Yag/KTP Laser System Family | 2009 |
| † | K140727 | Cutera Picosecond Laser System | 2014 |
| † | K133945 | Cutera Picosecond Laser System | 2014 |
What descends from it? (68)
See all 686 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 20 years and passes through 11 companies; a new generation was cleared every 10 months on median.
- 10 of the 253 ancestors have a recall of any class.
- Of its descendants, K153527 (Syneron Candela Corporation, 2016) has gone furthest, with 41 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. 2015, 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 PicoWay Laser System is indicated for the following at the specified wavelength:
532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The PicoWay Laser System is also indicated for benign pigmented lesions removal for 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/K150326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150326: PicoWay 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/K150326
Report an extraction error
Are you the manufacturer?
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