AQUADERM— 510(k) K885205

Substantially Equivalent for Some Indications

Laivan Corp.

FDA 510(k) clearance K885205 for AQUADERM, Substantially Equivalent for Some Indications on 1989-03-29. Applicant: Laivan Corp..

Clearance details

Applicant: Laivan Corp.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1988-12-19
Decision date: 1989-03-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: East Rockaway, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.