DeviceClearance

ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR— 510(k) K140782

Substantially Equivalent

Celleration, Inc.

FDA 510(k) clearance K140782 for ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR, Substantially Equivalent on 2014-08-13. Applicant: Celleration, Inc..

Clearance details

Applicant
Celleration, Inc.
Product code
Code NRB
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Eden Prairie, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code NRB

product code NRB
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.