510(k) clearances

AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors

Apyx Medical Corporation · General, Plastic Surgery

K261710Substantially EquivalentTraditionalQPB
Open FDA's page for this record
Third party flag
N
City
Clearwater
Advisory committee description
General, Plastic Surgery
Address 1
5115 Ulmerton Rd.
Statement or summary
Summary
Product code
QPB
Zip code
33760
Applicant
Apyx Medical Corporation
Decision date
2026-08-21
Decision code
SESE
Country code
US
Device name
AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors
Advisory committee
SU
Contact
Nikita Gajbhiye
K number
K261710
State
FL
Date received
2026-05-22
Review advisory committee
SU
Postal code
33760
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Suction, Lipoplasty For Removal
Medical specialty description
General, Plastic Surgery
Regulation number
878.5040
Device class
2
Registration number
3007279404, 3007697975, 2022994, 3022320321, 3038715747, 2027804, 3002807523, 1118193, 2028523, 3004112621, 1045254, 3030230686, 1047843, 1000655158, 3009039068, 3011163668, 2030580, 2435119, 1220246, 3009103001, 3018094310, 3008717566, 1645337, 3003755939, 3008837339, 3003587189, 1058584, 2032809, 3005670221, 2032098, 3038613815, 3011423170, 2523676, 3004878380, 1222928, 3006142527, 3006611221, 2020601, 3007829657, 3011533696 +9 more
FEI number
1000118360, 3007279404, 3007697975, 2022994, 3022320321, 3038715747, 1118193, 3002807523, 3004106598, 3002807634, 1000125732, 3004112621, 3005601686, 1317628, 1045254, 3030230686, 1047843, 1000655158, 3004169154, 3009039068, 1000518699, 3011163668, 3003058448, 2435119, 1220246, 1000125147, 3009103001, 3008717566, 3003755939, 3008837339, 1000120613, 3003587189, 1000219637, 3000206435, 3005670221, 3038613815, 3006142527, 2523676, 3004878380, 2020601 +9 more
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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.