Aveli
Model AVE002 · Revelle Aesthetics, Inc. · DI 00850036790013
FTD — Lamp, Surgical · Class II · 21 CFR 878.4580
GDI — Dissector, Surgical, General & Plastic Surgery · Class I · 21 CFR 878.4800
OUP — Powered Surgical Instrument For Improvement In The Appearance Of Cellulite · Class II · 21 CFR 878.4790
UDILibrary device dossier · generated 2026-09-11 · 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) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-05 | 0 | 1.5 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1.8 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 5 |
| 2020-06 | 0 | 2 |
| 2020-07 | 0 | 1.5 |
| 2020-08 | 0 | 6 |
| 2020-09 | 0 | 1.5 |
| 2020-10 | 0 | 2.5 |
| 2020-11 | 0 | 3.4 |
| 2020-12 | 0 | 1 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 1.33 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 2 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 3 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-04 | 0 | 1 |
| 2022-05 | 0 | 5 |
| 2022-06 | 0 | 2.5 |
| 2022-07 | 0 | 4 |
| 2022-08 | 0 | 3 |
| 2022-09 | 0 | 1.75 |
| 2022-10 | 0 | 2.38 |
| 2022-11 | 0 | 2 |
| 2022-12 | 0 | 1.14 |
| 2023-01 | 0 | 1.57 |
| 2023-02 | 0 | 3.33 |
| 2023-03 | 0 | 1.71 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 1.33 |
| 2023-06 | 0 | 1.78 |
| 2023-07 | 0 | 2.24 |
| 2023-08 | 0 | 1.57 |
| 2023-09 | 0 | 6.07 |
| 2023-10 | 0 | 1.86 |
| 2023-11 | 0 | 1.65 |
| 2023-12 | 0 | 1.67 |
| 2024-01 | 0 | 1.6 |
| 2024-02 | 0 | 1.71 |
| 2024-03 | 0 | 1.83 |
| 2024-04 | 0 | 2.6 |
| 2024-05 | 0 | 2.5 |
| 2024-06 | 0 | 2.55 |
| 2024-07 | 0 | 2.57 |
| 2024-08 | 0 | 8.67 |
| 2024-09 | 0 | 2 |
| 2024-10 | 0 | 2 |
| 2024-11 | 0 | 1.4 |
| 2024-12 | 0 | 1.63 |
| 2025-01 | 0 | 3.55 |
| 2025-02 | 0 | 1.86 |
| 2025-03 | 0 | 1.82 |
| 2025-04 | 0 | 1.57 |
| 2025-05 | 0 | 1.67 |
| 2025-06 | 0 | 2.44 |
| 2025-07 | 0 | 1.86 |
| 2025-08 | 0 | 1.36 |
| 2025-09 | 0 | 2.86 |
| 2025-10 | 0 | 1.8 |
| 2025-11 | 0 | 2.25 |
| 2025-12 | 0 | 2.5 |
| 2026-01 | 0 | 2 |
| 2026-02 | 0 | 1.33 |
| 2026-03 | 0 | 3.67 |
| 2026-04 | 0 | 3.33 |
| 2026-05 | 0 | 2 |
| 2026-06 | 0 | 2 |
Regulatory clearances
- K232153 SESE 2023-08-18 (k number procode)
- K221336 SESE 2022-08-05 (k number procode)
- K212399 SESE 2021-10-22 (k number procode)
Predicate lineage
K212399 — cites (transitively): K192185 (d1), K161885 (d2), K153677 (d3), K150505 (d4), K101231 (d5), K134010 (d5) — cited as predicate by K221336
K221336 — cites (transitively): K212399 (d1), K192185 (d2), K161885 (d3), K153677 (d4), K150505 (d5), K101231 (d6), K134010 (d6) — cited as predicate by K232153
K232153 — cites (transitively): K111020 (d1), K221336 (d1), K041681 (d2), K212399 (d2), K192185 (d3), K161885 (d4), K153677 (d5), K150505 (d6), K101231 (d7), K134010 (d7)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Revelle Aesthetics, Inc.
Nothing in the loaded window.