510(k) · Cleared
ClearedFractional CO2 Laser Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhengzhou PZ Laser Slim Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 12, 2025 as substantially equivalent to K172096 (Ilooda Co,., Ltd., 2017) after a 90-day review. Its family tree reaches back 20 generations to 1995.
- Decided
- Jun 12, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K943450 (1995). 282 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK130501 IntensifEndymed Medical, Ltd. · 2014
- 2 generations backK160312 Fraxis DuoIlooda Co,., Ltd. · 2016
- 1 generation backK172096 FraxisIlooda Co,., Ltd. · 2017
- This deviceK250782 Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd. · 2025
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 8 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 7 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 6 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 5 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 4 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 3 generations backK130501 IntensifEndymed Medical, Ltd. · 2014
- 2 generations backK160312 Fraxis DuoIlooda Co,., Ltd. · 2016
- 1 generation backK172096 FraxisIlooda Co,., Ltd. · 2017
- This deviceK250782 Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −8 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −7 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −6 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −5 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −4 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| −3 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| −2 | K160312 | Fraxis Duo | Ilooda Co,., Ltd. | 2016 | — |
| −1 | K172096 | Fraxis | Ilooda Co,., Ltd. | 2017 | — |
| 0 (this device) | K250782 | Fractional CO2 Laser Machine | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 14 | 0 |
| 1996 | 20 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 21 | 0 |
| 2001 | 23 | 0 |
| 2002 | 30 | 0 |
| 2003 | 26 | 0 |
| 2004 | 14 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K172096 | FraxisSummary page 6…Product Code: GEX, ONG Regulation Number: 878.4810 Review Panel: General & Plastic Surgery 5. Identification of Predicate Device(s) 510(k) Number: K172096 Product Name: Ilooda Fraxis CO2 Laser Manufacturer: Ilooda Co. LTD 6. Device Description The Fractional CO2… | 2017 |
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 7 companies; a new generation was cleared every 11 months on median.
- 10 of the 282 ancestors have a recall of any class.
- 1 other device also cites its predicate K172096.
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?
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode (Impulse mode) is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250782 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250782: Fractional CO2 Laser Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250782
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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