Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Lumenis Be Ltd. with 8 510(k) clearances. The most recent is a 510(k) clearance dated Sep 19, 2026: SmartIPL_NI System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 19, 2026 | SmartIPL_NI SystemK241973 · GEX | 510(k) clearances |
| Jun 2, 2026 | MILAN SystemK253803 · GEI | 510(k) clearances |
| Apr 16, 2025 | Stellar M22K250809 · GEX | 510(k) clearances |
| Sep 9, 2024 | FoLixK242349 · GEX | 510(k) clearances |
| Dec 1, 2023 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and AccessoriesK233301 · GEX | 510(k) clearances |
| Jun 14, 2023 | F65 Laser SystemK222790 · OAP | 510(k) clearances |
| Jul 15, 2022 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsK220877 · HQF | 510(k) clearances |
| May 18, 2022 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and AccessoriesK220467 · GEX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
