Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Nir Handpiece For Harmony Lite/ Spa Shr Pro (6cm)

Model 1 · ALMA LASERS LTD. · DI 17290110120563

ONF — Powered Light Based Non-Laser Surgical Instrument With Thermal Effect · Class II · 21 CFR 878.4810

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.

358112019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 4/device2019-05: 0 reports for this device; peer average 8/device2019-06: 0 reports for this device; peer average 4/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2.5/device2019-11: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 4/device2020-02: 0 reports for this device; peer average 4/device2020-03: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 4/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 4/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1.33/device2021-02: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1.5/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1.4/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 3.33/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 3/device2024-06: 0 reports for this device; peer average 2.5/device2024-07: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 3/device2024-11: 0 reports for this device; peer average 3/device2025-02: 0 reports for this device; peer average 4/device2025-03: 0 reports for this device; peer average 6/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 2.5/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 5/device2025-11: 0 reports for this device; peer average 2.67/device2025-12: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 6.33/device2026-03: 0 reports for this device; peer average 10.5/device2026-04: 0 reports for this device; peer average 2.67/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 6/device0102030506080911120102030406070912010207080911120811030406070910111201020304050607091102030405060708091011120203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0202
2019-0304
2019-0508
2019-0604
2019-0802
2019-0902.5
2019-1102
2019-1201.5
2020-0104
2020-0204
2020-0302
2020-0404
2020-0602
2020-0702
2020-0904
2020-1201
2021-0101.33
2021-0201
2021-0701.5
2021-0802
2021-0901
2021-1101
2021-1201
2022-0801
2022-1101
2023-0302
2023-0401.4
2023-0602
2023-0702
2023-0901
2023-1002
2023-1103.33
2023-1201
2024-0101
2024-0201
2024-0301
2024-0402
2024-0503
2024-0602.5
2024-0701
2024-0903
2024-1103
2025-0204
2025-0306
2025-0401.5
2025-0502
2025-0602
2025-0702
2025-0802.5
2025-0902
2025-1005
2025-1102.67
2025-1202
2026-0206.33
2026-03010.5
2026-0402.67
2026-0502
2026-0606
This device (reports/month)Average device in ONF (reports/device/month)

Regulatory clearances

  • K141237 SESE 2015-03-13 (k number procode)

Predicate lineage

K141237 — cites (transitively): K072564 (d1), K140009 (d1), K033768 (d2), K042165 (d2), K050370 (d2), K080318 (d2), K083207 (d2), K083848 (d2), K090571 (d2), K101916 (d2), K102716 (d2), K112031 (d2), K023881 (d3), K042630 (d3), K050382 (d3), K060033 (d3), K070284 (d3), K070388 (d3), K072868 (d3), K081324 (d3), K081352 (d3), K082225 (d3), K082230 (d3), K083613 (d3), K083899 (d3), K090195 (d3), K100270 (d3), K101506 (d3), K052874 (d3), K024088 (d4), K032863 (d4), K050824 (d4), K071295 (d4), K072682 (d4), K073063 (d4), K080121 (d4), K083682 (d4), K090164 (d4), K902871 (d4), K923599 (d4), K944474 (d4), K944704 (d4), K944965 (d4), K951760 (d4), K992866 (d4), K033549 (d4), K071768 (d4), K073583 (d4), K083900 (d4), K091446 (d4), K060301 (d4), K063571 (d4), K071152 (d4), K080244 (d4) — cited as predicate by K152790, K153717, K160075, K181298, K230308

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

Manufacturer compliance record — ALMA LASERS LTD.

  • Warning Letter 2013-06-07 Alma Lasers, Inc.
  • Warning Letter 2013-06-07 Alma Lasers, Inc.
  • NAI 2013-12-11 Alma Lasers, Inc. · 0 citations
  • NAI 2013-12-11 Alma Lasers, Inc. · 0 citations
  • OAI 2013-01-29 Alma Lasers, Inc. · 0 citations
  • OAI 2013-01-29 Alma Lasers, Inc. · 0 citations