FDA applicant
Heraeus Lasersonics, Inc.
FDA records 38 decisions for Heraeus Lasersonics, Inc. (Milpitas, CA) from 1988 to 1994: 38 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and HQF (Laser, Ophthalmic). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Heraeus Lasersonics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Heraeus Lasersonics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Heraeus Lasersonics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Heraeus”
FDA records each applicant name separately; these may or may not be the same firm.