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DEKA PHYSIQ 360

Model M134A1 · DEKA M.E.L.A. SRL · DI 08057017760689

PKT — Laser For Disruption Of Adipocyte Cells For Aesthetic Use · Class II · 21 CFR 878.5400

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.

12342019-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 4/device2021-12: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 1.5/device02030712080307091104
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0202
2020-0302
2021-0704
2021-1202
2022-0802
2024-0301
2025-0702
2025-0901
2025-1102
2026-0401.5
This device (reports/month)Average device in PKT (reports/device/month)

Regulatory clearances

  • K231971 SESE 2023-09-26 (k number procode)

Predicate lineage

K231971 — cites (transitively): K171992 (d1), K162050 (d2), K171111 (d2), DEN090002 (d3), K133212 (d3), K142491 (d3), K160259 (d3), K160470 (d3), K080521 (d4), K120023 (d4), K151179 (d4), K150230 (d4), K150724 (d4), K083795 (d5), K123971 (d5), K083595 (d6), K100230 (d6), K083629 (d7)

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

Manufacturer compliance record — DEKA M.E.L.A. SRL

Nothing in the loaded window.