Cleared Traditional

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

K261582 is an FDA 510(k) clearance for Vacuum Roller RF Slimming Device for Me..., manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code NUV cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K261582 · Zhengzhou PZ Laser Slim Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
107d
Days
Class 2
Risk

K261582 is an FDA 510(k) clearance for the Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02). Classified as Massager, Vacuum, Light Induced Heating (product code NUV), Class II - Special Controls.

Submitted by Zhengzhou PZ Laser Slim Technology Co., Ltd. (Zhengzhou, CN). The FDA issued a Cleared decision on August 28, 2026 after a review of 107 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhengzhou PZ Laser Slim Technology Co., Ltd. devices

FDA 510(k) Submission Details - K261582

510(k) Number K261582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2026
Decision Date August 28, 2026
Days to Decision 107 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 115d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUV Device Classification - Class 2, Special Controls

Product Code NUV Massager, Vacuum, Light Induced Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended To Temporarily Alter The Appearance Of Cellulite
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NUV Massager, Vacuum, Light Induced Heating

All 11
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