510(k) · Cleared
ClearedND YAG Q-switch Laser Therapy Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Adss Development Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Feb 22, 2017 as substantially equivalent to K072564 (Alma Lasers, Ltd., 2008) after a 224-day review. Its family tree reaches back 15 generations to 1995. 5 later devices descend from it.
- Decided
- Feb 22, 2017
- Review
- 224 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K943450 (1995). 239 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK161926 ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK232716 Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK193464 ND:YAG LaserBeijing Superlaser Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK260153 Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK250722 Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK231948 MediyagMedicreations, LLC · 2024
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK161926 ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd. · 2017
Most influential descendants
Showing 5 of 5 · See all- K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd. · 2023 · cites it directly1descendant
- K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd. · 2020 · cites it directly1descendant
- K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd. · 2026 · 2 generations on0descendants
- K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd. · 2025 · 2 generations on0descendants
- K231948MediyagMedicreations, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −2 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| 0 (this device) | K161926 | ND YAG Q-switch Laser Therapy Machine | Beijing Adss Development Co., Ltd. | 2017 | — |
| +1 | K232716 | Q-Switched Nd:Yag laser | Hebei Zhemai Technology Co., Ltd. | 2023 | — |
| +1 | K193464 | ND:YAG Laser | Beijing Superlaser Technology Co., Ltd. | 2020 | — |
| +2 | K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | 2026 | — |
| +2 | K250722 | Nd: YAG Laser Therapy System (QN-1) | Hebei JT Medical Co., Ltd. | 2025 | — |
| +1 | K231948 | Mediyag | Medicreations, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 11 | 0 |
| 1996 | 16 | 0 |
| 1997 | 21 | 0 |
| 1998 | 15 | 0 |
| 1999 | 9 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 30 | 0 |
| 2003 | 21 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 6…3‐2 510(k) Summary 6. Identification of Predicate Device Predicate Device： 510(k) Number K072564 Predicate Device Name Harmony XL Multiple Application Platform Manufacturer Alma Laser, Ltd 7. Non-C… | 2008 |
What descends from it? (5)
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 22 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 9 of the 239 ancestors have a recall of any class.
- Of its descendants, K232716 (Hebei Zhemai Technology Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 19 other devices also cite its predicate K072564.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161926: ND YAG Q-switch Laser Therapy Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161926
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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