Tone Applicator
Model AG608499A · INMODE M.D LTD · DI 07290016633566
GZL — Electrode, Depth · Class II · 21 CFR 882.1330
IPF — Stimulator, Muscle, Powered · Class II · 21 CFR 890.5850
UDILibrary device dossier · generated 2026-09-15 · 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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.5 |
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 1 |
| 2019-04 | 0 | 1.5 |
| 2019-05 | 0 | 1.5 |
| 2019-06 | 0 | 2 |
| 2019-10 | 0 | 1.5 |
| 2019-11 | 0 | 1.67 |
| 2019-12 | 0 | 2.25 |
| 2020-01 | 0 | 2 |
| 2020-02 | 0 | 2.44 |
| 2020-03 | 0 | 1 |
| 2020-06 | 0 | 2 |
| 2020-07 | 0 | 2 |
| 2020-08 | 0 | 1.33 |
| 2020-09 | 0 | 2.25 |
| 2020-10 | 0 | 1.25 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 1 |
| 2021-08 | 0 | 1.2 |
| 2021-09 | 0 | 1.25 |
| 2021-10 | 0 | 1 |
| 2022-01 | 0 | 2 |
| 2022-05 | 0 | 2.5 |
| 2022-06 | 0 | 1.5 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 2 |
| 2022-11 | 0 | 1 |
| 2023-01 | 0 | 1.67 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 2.4 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 2.5 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 1 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1.75 |
| 2024-01 | 0 | 3 |
| 2024-02 | 0 | 2.5 |
| 2024-03 | 0 | 2.5 |
| 2024-05 | 0 | 3.75 |
| 2024-06 | 0 | 1.5 |
| 2024-07 | 0 | 2 |
| 2024-09 | 0 | 1.5 |
| 2024-10 | 0 | 3 |
| 2024-11 | 0 | 2.25 |
| 2024-12 | 0 | 2.5 |
| 2025-01 | 0 | 2 |
| 2025-02 | 0 | 3 |
| 2025-03 | 0 | 2 |
| 2025-05 | 0 | 2.25 |
| 2025-06 | 0 | 1 |
| 2025-07 | 0 | 2.5 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 4.5 |
| 2026-02 | 0 | 1 |
| 2026-05 | 0 | 3 |
| 2026-06 | 0 | 2.5 |
Regulatory clearances
- K201285 SESE 2021-03-05 (k number procode)
- K192249 SESE 2019-12-17 (k number procode)
Predicate lineage
K192249 — cites (transitively): K132284 (d1), K040662 (d2), K062354 (d2), K900519 (d2), K970426 (d2) — cited as predicate by K201285, K202079, K213308
K201285 — cites (transitively): K183450 (d1), K192249 (d1), K131362 (d2), K172302 (d2), K132284 (d2), K090221 (d3), K040662 (d3), K062354 (d3), K900519 (d3), K970426 (d3), K153568 (d3), K150035 (d4), K142093 (d5), K133837 (d6), K113810 (d7) — cited as predicate by K210877, K240992, K241433
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — INMODE M.D LTD
Nothing in the loaded window.