# K261582: Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)

- Pathway: 510(k) (Traditional)
- Applicant: Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Decided: Aug 28, 2026 after 107 days
- Product code: NUV (Massager, Vacuum, Light Induced Heating)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K943450 (1995). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161892: Slimming Treatment Device, Beijing Honkon Technologies Co., Ltd. (2017) Summary page 9.
- K122579: Velashape, Syneron Medical, Ltd. (2012) Summary page 9.

## Indications for use
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.

Source page: https://510kreport.com/device/K261582
Methodology: https://510kreport.com/methodology