Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwitzerlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list SIE AG, Surgical Instrument Engineering with 4 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Apr 21, 2022: FEMTO LDV Z8 Femtosecond Surgical Laser.
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.
| Apr 21, 2022 | FEMTO LDV Z8 Femtosecond Surgical LaserK213559 · OOE | 510(k) clearances |
| Jan 21, 2018 | The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended Class II · This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complic | Device recalls |
| Oct 23, 2015 | FEMTO LDV Z8 Surgical LaserK150323 · OOE | 510(k) clearances |
| Mar 16, 2012 | FEMTO LDVK112154 · HQF | 510(k) clearances |
| Mar 10, 2006 | DA VINCI FEMTOSECOND SURGICAL LASERK053511 · 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
