510(k) · Cleared
ClearedPicosecond Laser Device (PF131-BI)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Risu Medical Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Oct 23, 2025 as substantially equivalent to K200116 (Shanghai Apolo Medical Technology Co., Ltd., 2020) and 3 other predicates after an 87-day review. Its family tree reaches back 29 generations to 1995.
- Decided
- Oct 23, 2025
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 29 generations to K943450 (1995). 325 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 29 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 25 generations between
- 3 generations backK173700 PICOPLUS Laser SystemLutronic Corporation · 2018
- 2 generations backK200116 PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- 1 generation backK220268 Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd. · 2022
- This deviceK252345 Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd. · 2025
Show all 29 generations
- Root · 29 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 28 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 27 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 26 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 25 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 24 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 23 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 22 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 21 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 20 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 19 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 18 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 17 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 16 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 15 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 14 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 13 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 12 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 11 generations backK133364 Picosure WorkstationCynosure, Inc. · 2014
- 10 generations backK140719 Picosure WorkstationCynosure, Inc. · 2014
- 9 generations backK143105 Picosure WorkstationCynosure, Inc. · 2015
- 8 generations backK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 7 generations backK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 6 generations backK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 5 generations backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 4 generations backK172077 Cutera enlighten III Laser SystemCutera, Inc. · 2017
- 3 generations backK173700 PICOPLUS Laser SystemLutronic Corporation · 2018
- 2 generations backK200116 PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- 1 generation backK220268 Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd. · 2022
- This deviceK252345 Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −29 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −28 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −27 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −26 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −25 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −24 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −23 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −22 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −21 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −20 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −19 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −18 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −17 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −16 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −15 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −14 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −13 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −12 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −11 | K133364 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −10 | K140719 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −9 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| −8 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −7 | K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −6 | K162454 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| −5 | K170597 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| −4 | K172077 | Cutera enlighten III Laser System | Cutera, Inc. | 2017 | — |
| −3 | K173700 | PICOPLUS Laser System | Lutronic Corporation | 2018 | — |
| −2 | K200116 | PicoSecond Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| −1 | K220268 | Picosecond Laser System (Model PS10-A and PS10-B) | Beijing Adss Development Co., Ltd. | 2022 | — |
| 0 (this device) | K252345 | Picosecond Laser Device (PF131-BI) | Risu Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 12 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 24 | 0 |
| 1998 | 16 | 0 |
| 1999 | 11 | 0 |
| 2000 | 26 | 0 |
| 2001 | 26 | 0 |
| 2002 | 35 | 0 |
| 2003 | 24 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K200116 | PicoSecond Nd: YAG Laser SystemSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code K200116 PicoSecond Nd: YAG Laser System GEX K1 91685… | 2020 |
| * | K191685 | PicoWay Laser SystemSummary page 5…Product Code K200116 PicoSecond Nd: YAG Laser System GEX K1 91685 PicoWay Laser System GEX K23300 7… | 2019 |
| * | K233007 | Picosecond Nd:YAG Laser System; PICO LEGENDSummary page 5…GEX K1 91685 PicoWay Laser System GEX K23300 7 PICO LEGEND Nd:YAG Laser System GEX K220268… | 2024 |
| * | K220268 | Picosecond Laser System (Model PS10-A and PS10-B)Summary page 5…GEX K23300 7 PICO LEGEND Nd:YAG Laser System GEX K220268 Picosecond Laser System GEX Device Descr… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 15 companies; a new generation was cleared every 9 months on median.
- 16 of the 325 ancestors have a recall of any class.
- 5 other devices also cite its predicate K200116.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Picosecond Laser device is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252345 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252345: Picosecond Laser Device (PF131-BI).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252345
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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