DeviceClearance

ELEVARE, PERFECTIO 4— 510(k) K172909

Substantially Equivalent

Omm Imports D/B/A Zero Gravity

FDA 510(k) clearance K172909 for ELEVARE, PERFECTIO 4, Substantially Equivalent on 2018-06-07. Applicant: Omm Imports D/B/A Zero Gravity. Device class: 2.

Clearance details

Applicant
Omm Imports D/B/A Zero Gravity
Product code
Code OHS
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Doral, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code OHS

view all

Adverse events under product code OHS

product code OHS
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.