HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100— 510(k) K895430

Substantially Equivalent

Heraeus Lasersonics, Inc.

FDA 510(k) clearance K895430 for HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100, Substantially Equivalent on 1989-11-28. Applicant: Heraeus Lasersonics, Inc..

Clearance details

Applicant: Heraeus Lasersonics, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1989-09-05
Decision date: 1989-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.