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AYON Body Contouring System

Model AYON · APYX MEDICAL CORPORATION · DI 00607151050993

QPB — System, Suction, Lipoplasty For Removal · Class II · 21 CFR 878.5040

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

11222020-03: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 1/device0306080906100306
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0301
2022-0601
2022-0801
2022-0901
2025-0602
2025-1002
2026-0302
2026-0601
This device (reports/month)Average device in QPB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K244050 — cites (transitively): K031432 (d1), K110306 (d1), K161722 (d1), K981215 (d1), K991437 (d1), K022051 (d2) — cited as predicate by K253396

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — APYX MEDICAL CORPORATION

  • VAI 2015-07-30 Apyx Medical Corporation · 4 citations
  • VAI 2015-07-30 Apyx Medical Corporation · 4 citations
  • NAI 2013-04-25 Bovie-Bulgaria LTD · 0 citations
  • VAI 2012-01-18 Apyx Medical Corporation · 2 citations
  • VAI 2012-01-18 Apyx Medical Corporation · 2 citations