DeviceClearance

The Cellfina System— 510(k) K161885

Substantially Equivalent

Ulthera, Inc.

FDA 510(k) clearance K161885 for The Cellfina System, Substantially Equivalent on 2016-10-05. Applicant: Ulthera, Inc.. Device class: 2.

Clearance details

Applicant
Ulthera, Inc.
Product code
Code OUP
Device class
Class 2
Regulation
21 CFR 878.4790
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mesa, AZ, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K161885

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161885.

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