510(k) · Cleared
ClearedVacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhengzhou PZ Laser Slim Technology Co., Ltd. · NUV Massager, Vacuum, Light Induced Heating
Cleared on Aug 28, 2026 as substantially equivalent to K161892 (Beijing Honkon Technologies Co., Ltd., 2017) and 1 other predicate after a 107-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- Aug 28, 2026
- Review
- 107 days
- Class
- Class II
- Product code
- NUV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K943450 (1995). 67 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- 2 generations backK090221 Reaction SystemViora, Ltd. · 2009
- 1 generation backK161892 Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd. · 2017
- This deviceK261582 Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01…Zhengzhou PZ Laser Slim Technology Co., Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 5 generations backK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- 4 generations backK071872 VelashapeSyneron Medical, Ltd. · 2007
- 3 generations backK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- 2 generations backK090221 Reaction SystemViora, Ltd. · 2009
- 1 generation backK161892 Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd. · 2017
- This deviceK261582 Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01…Zhengzhou PZ Laser Slim Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −5 | K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | 2007 | — |
| −4 | K071872 | Velashape | Syneron Medical, Ltd. | 2007 | — |
| −3 | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
| −2 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| −1 | K161892 | Slimming Treatment Device | Beijing Honkon Technologies Co., Ltd. | 2017 | — |
| 0 (this device) | K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 NUV? 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 NUV device
- #1 K231092 T-Shape 2score 11.4 · 19 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K161892 | Slimming Treatment DeviceSummary page 9…)Summary DC contactor Connect or disconnect the DC main circuit with load. 6 Identification of Predicate Device Predicate Device1 510(k) Number: K161892 Product Name: Slimming Treatment Device Manufacturer: Beijing Honkon Technologies Co., Ltd Predicate Device 2 510(k) Number… | 2017 |
| * | K122579 | VelashapeSummary page 9…dicate Device1 510(k) Number: K161892 Product Name: Slimming Treatment Device Manufacturer: Beijing Honkon Technologies Co., Ltd Predicate Device 2 510(k) Number: K122579 Product Name: VelaShape Manufacturer: Syneron Medical, Limited 7 Non-Clinical Test Conclusion Non-clinical tests were condu… | 2012 |
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 31 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 4 of the 67 ancestors have a recall of any class.
How does its category compare?
All NUV devicesNUV Massager, Vacuum, Light Induced Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NUV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NUV
99in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUV
No recall names NUV since 2007.
Adverse event reports per year · NUV
1in 2020
MAUDE reports naming product code NUV, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 99 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Vacuum Roller RF Slimming Device for Medical Use incorporates four therapeutic technologies: radiofrequency (RF), infrared (IR), vacuum, and mechanical roller massage. The device provides the following treatment modes: • Mode 1 - Massage & IR Therapy: Vacuum + IR + Roller Massage • Mode 2 - RF Massage Therapy: RF + Vacuum + Roller Massage • Mode 3 - Vacuum/IR Body Contouring: Vacuum + IR • Mode 4 - Massage Therapy: Vacuum + Roller Massage • Mode 5 -…
Read the full statement (172 words)
The Vacuum Roller RF Slimming Device for Medical Use incorporates four therapeutic technologies: radiofrequency (RF), infrared (IR), vacuum, and mechanical roller massage. The device provides the following treatment modes:
• Mode 1 - Massage & IR Therapy: Vacuum + IR + Roller Massage
• Mode 2 - RF Massage Therapy: RF + Vacuum + Roller Massage
• Mode 3 - Vacuum/IR Body Contouring: Vacuum + IR
• Mode 4 - Massage Therapy: Vacuum + Roller Massage
• Mode 5 - IR Massage Therapy: IR + Roller Massage
The device is indicated for the following uses:
• Modes 1, 2, 5 are indicated for the temporary relief of minor muscle aches and pain.
• Modes 1, 2, 5 are indicated for the temporary relief of muscle spasm.
• Modes 1, 2, 5 are indicated for the temporary improvement of local blood circulation.
• Modes 1, 2, 3, 4 are indicated for the temporary reduction in the appearance of cellulite.
• Modes 1, 3, 5 are indicated for the temporary reduction of thigh circumference.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261582: Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261582
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026