Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)— 510(k) K261582
Substantially EquivalentZhengzhou PZ Laser Slim Technology Co., Ltd.
FDA 510(k) clearance K261582 for Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02), Substantially Equivalent on 2026-08-28. Applicant: Zhengzhou PZ Laser Slim Technology Co., Ltd.. Device class: 2.
Summary
Zhengzhou PZ Laser Slim Technology filed the Vacuum Roller RF Slimming Device for Medical Use, models PZ-FY66-01 and PZ-FY66-02. The product code is NUV, vacuum massagers with light induced heating.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. The submission was a Traditional 510(k).
The company filed from Zhengzhou, China. The decision came 107 calendar days after FDA received it (May 13 to August 28, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Product code
- Product code NUV
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhengzhou, CN
Recent devices under product code NUV
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Data sourced from openFDA. This site is unofficial and independent of the FDA.