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 Sep 16, 2019 as substantially equivalent to K170597 (Syneron Candela Corporation, 2017) after an 84-day review. Its family tree reaches back 25 generations to 1995. 20 later devices descend from it.
- Decided
- Sep 16, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 25 generations to K943450 (1995). 286 ancestors in all, the oldest K800617 (1980). 20 later devices descend from it, 8 citing it directly.
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations between
- 3 generations backK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 2 generations backK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 1 generation backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
- This deviceK191685 PicoWay Laser SystemCandela Corporation · 2019
- Descendant · cites it directly · 6 of its ownK200116 PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- Descendant · cites it directly · 5 of its ownK201773 PicohiHironic Co., Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK202172 StarWalkerFotona D.O.O. · 2020
- Descendant · 2 generations on · 2 of its ownK234104 PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK253342 PICO-KSpeclipse, Inc. · 2025
Show all 25 generations
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 21 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 20 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 19 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 18 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 17 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 14 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 13 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 12 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 11 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 10 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 9 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 8 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 7 generations backK133364 Picosure WorkstationCynosure, Inc. · 2014
- 6 generations backK140719 Picosure WorkstationCynosure, Inc. · 2014
- 5 generations backK143105 Picosure WorkstationCynosure, Inc. · 2015
- 4 generations backK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 3 generations backK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 2 generations backK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 1 generation backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
- This deviceK191685 PicoWay Laser SystemCandela Corporation · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd. · 2020 · cites it directly6descendants
- K201773PicohiHironic Co., Ltd. · 2021 · cites it directly5descendants
- K202172StarWalkerFotona D.O.O. · 2020 · cites it directly3descendants
- K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd. · 2024 · 2 generations on2descendants
- K253342PICO-KSpeclipse, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −24 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −21 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −20 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −19 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −18 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −17 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −14 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −13 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −12 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −11 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −10 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −9 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −8 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −7 | K133364 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −6 | K140719 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −5 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| −4 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −3 | K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −2 | K162454 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| −1 | K170597 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| 0 (this device) | K191685 | PicoWay Laser System | Candela Corporation | 2019 | — |
| +1 | K200116 | PicoSecond Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| +1 | K201773 | Picohi | Hironic Co., Ltd. | 2021 | — |
| +1 | K202172 | StarWalker | Fotona D.O.O. | 2020 | — |
| +2 | K234104 | PICOANDY (Q-Switched Nd:YAG Laser) | Wontech Co., Ltd. | 2024 | — |
| +2 | K253342 | PICO-K | Speclipse, Inc. | 2025 | — |
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 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 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? (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 |
|---|---|---|---|
| * | K170597 | PicoWay Laser SystemSummary page 5…for use in General and Plastic Surgery and in Dermatology (21 CFR 878.4810) Product Code: GEX Predicates Primary Predicate: Candela Corporation’s PicoWay Laser System (K170597) Reference Predicates: Cynosure PicoSure (K160480), Cutera Enlighten III (K172077), Syneron‐Candela PicoWay (K160607) Intended… | 2017 |
| † | K160480 | PicoSure Workstation | 2016 |
| † | K172077 | Cutera enlighten III Laser System | 2017 |
| † | K160607 | PicoWay Laser System | 2016 |
What descends from it? (20)
See all 208 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200116 | PicoSecond Nd: YAG Laser System | 2020 | 6 |
| K201773 | Picohi | 2021 | 5 |
| K202172 | StarWalker | 2020 | 3 |
| K242534 | HandPICO Fractional Laser Handpiece Tip | 2024 | 1 |
| K220853 | PicoWay Laser System | 2022 | 1 |
| K251981 | Boston PICO (Boston PICO) | 2026 | 0 |
| K252345 | Picosecond Laser Device (PF131-BI) | 2025 | 0 |
| K240386 | Picosecond Nd:YAG Laser Systems (BL-C10) | 2024 | 0 |
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 24 years and passes through 11 companies; a new generation was cleared every 9 months on median.
- 11 of the 286 ancestors have a recall of any class.
- Of its descendants, K200116 (Shanghai Apolo Medical Technology Co., Ltd., 2020) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K170597.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 532 nm: Removal of tattoos for Fitzpatrick skin types I‐III to treat the following tattoo colors: red, yellow and orange. 730 nm: Removal of tattoos for Fitzpatrick skin types II‐IV to treat the following tattoo colors: green and blue. 785 nm: Removal of tattoos for Fitzpatrick skin types II‐IV to treat the following tattoo colors: green and blue. 1064 nm: Removal of…
Read the full statement (194 words)
The PicoWay laser system is indicated for the following at the specified wavelength
532 nm: Removal of tattoos for Fitzpatrick skin types I‐III to treat the following tattoo colors: red,
yellow and orange.
730 nm: Removal of tattoos for Fitzpatrick skin types II‐IV to treat the following tattoo colors: green
and blue.
785 nm: Removal of tattoos for Fitzpatrick skin types II‐IV to treat the following tattoo colors: green
and blue.
1064 nm: 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.
The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick
Skin Types II‐V.
The Resolve handpieces (532 nm HE, 532nm, 1064nm) are also indicated for treatment of wrinkles
in Fitzpatrick Skin Types I‐IV
The Resolve Fusion handpiece (1064 nm) is indicated for the treatment of wrinkles as well as benign pigmented lesions in
Fitzpatrick Skin Types I‐IV
The Resolve Fusion handpiece (532 nm) is indicated for the treatment of benign pigmented lesions in Fitzpatrick Skin
Types I‐IV
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K191685: PicoWay Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191685
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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