510(k) K261582

Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) by Zhengzhou PZ Laser Slim Technology Co., Ltd. — Product Code NUV

K261582 is an FDA 510(k) premarket notification submitted by Zhengzhou PZ Laser Slim Technology Co., Ltd. for the device "Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)". The FDA issued a decision of Substantially Equivalent on August 28, 2026. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. Zhengzhou PZ Laser Slim Technology Co., Ltd. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2026
Date Received
May 13, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Light Induced Heating
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

The device is intended to temporarily alter the appearance of cellulite