510(k) clearances

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

Zhengzhou PZ Laser Slim Technology Co., Ltd. · General, Plastic Surgery

K261582Substantially EquivalentTraditionalNUV
Open FDA's page for this record
Third party flag
N
City
Zhengzhou
Advisory committee description
General, Plastic Surgery
Address 1
3rd Floor, Bldg. 1, #101 Jinbai Rd., High-Tech Development Z
Statement or summary
Summary
Product code
NUV
Zip code
450001
Applicant
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Decision date
2026-08-28
Decision code
SESE
Country code
CN
Device name
Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
Advisory committee
SU
Contact
Junmei Li
K number
K261582
Date received
2026-05-13
Review advisory committee
SU
Postal code
450001
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Massager, Vacuum, Light Induced Heating
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3009488834, 3004167969, 3006807694, 3007712511, 3009736547, 3016496662, 3011782009, 3003015433, 3025104654, 3002808227, 3006716777, 1222993, 3013517454, 3017132875, 3008729892, 3005695724, 3034995492, 3010511300, 3013917867, 3013539104, 3013613043
FEI number
3009488834, 3004167969, 3006807694, 3007712511, 3002807555, 3009736547, 3016496662, 3003015433, 3025104654, 3002808227, 3006716777, 3013517454, 3017132875, 3010666513, 1000120578, 3005695724, 3034995492, 3010511300, 3013917867, 3013539104, 3013613043
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.