510(k) · Cleared
ClearedPicocaremajesty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wontech Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 7, 2022 as substantially equivalent to K181272 (Wontech Co., Ltd., 2018) and 1 other predicate after a 184-day review. Its family tree reaches back 23 generations to 1995. 6 later devices descend from it.
- Decided
- Jan 7, 2022
- Review
- 184 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 23 generations to K943450 (1995). 288 ancestors in all, the oldest K800617 (1980). 6 later devices descend from it, 3 citing it directly.
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations between
- 3 generations backK143105 Picosure WorkstationCynosure, Inc. · 2015
- 2 generations backK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 1 generation backK181272 Picocare FamilyWontech Co., Ltd. · 2018
- This deviceK212127 PicocaremajestyWontech Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK233018 PICOSECOND Nd:YAG Laser SystemIds, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK233007 Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253829 Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252345 Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK240474 Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd · 2024
Show all 23 generations
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 19 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 18 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 17 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 16 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 15 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 11 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 10 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 9 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 8 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 7 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 6 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 5 generations backK133364 Picosure WorkstationCynosure, Inc. · 2014
- 4 generations backK140719 Picosure WorkstationCynosure, Inc. · 2014
- 3 generations backK143105 Picosure WorkstationCynosure, Inc. · 2015
- 2 generations backK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 1 generation backK181272 Picocare FamilyWontech Co., Ltd. · 2018
- This deviceK212127 PicocaremajestyWontech Co., Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd. · 2023 · cites it directly2descendants
- K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. · 2024 · cites it directly1descendant
- K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd. · 2026 · cites it directly0descendants
- K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −22 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −19 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −18 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −17 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −16 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −15 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −11 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −10 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −9 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −8 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −7 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −6 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −5 | K133364 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −4 | K140719 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −3 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| −2 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −1 | K181272 | Picocare Family | Wontech Co., Ltd. | 2018 | — |
| 0 (this device) | K212127 | Picocaremajesty | Wontech Co., Ltd. | 2022 | — |
| +1 | K233018 | PICOSECOND Nd:YAG Laser System | Ids, Ltd. | 2023 | — |
| +1 | K233007 | Picosecond Nd:YAG Laser System; PICO LEGEND | Ami, Inc. | 2024 | — |
| +1 | K253829 | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing HuaCheng Taike Technology Co., Ltd. | 2026 | — |
| +2 | K252345 | Picosecond Laser Device (PF131-BI) | Risu Medical Technology Co., Ltd. | 2025 | — |
| +2 | K240474 | Multi-function Platform Systems (BL-M10) | Shanghai Bele Medical Technology Co.,Ltd | 2024 | — |
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 | 11 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 22 | 0 |
| 1998 | 16 | 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 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K181272 | Picocare FamilySummary page 5…807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate device 510(k) Number: K181272 Applicant: WON TECH Co., Ltd. Classification Name: Powered Laser… | 2018 |
| * | K200166 | Mirus Ligating Clip, Mirus Ligating Clip ApplierSummary page 5…Powered Laser Surgical Instrument Trade Name: Picocare Family Predicate device 510(k) Number: K200166 Applicant: Shanghai Apolo Medical Technology Co., Ltd. Classification Name:… | 2020 |
What descends from it? (6)
3 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 27 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 12 of the 288 ancestors have a recall of any class.
- Of its descendants, K233018 (Ids, Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K181272.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 PICOCAREMAIJESTY Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)
532nm
The 532nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-I1I
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/K212127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212127: Picocaremajesty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212127
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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