510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192185Substantially Equivalent

The Cellfina System

Merz North America, Inc., Mesa AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192185 is the FDA 510(k) clearance record for The Cellfina System, a class II device, cleared for Ulthera, Inc. on under FDA product code OUP (Powered Surgical Instrument For Improvement In The Appearance Of Cellulite). FDA's definition for product code OUP reads: "Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite". FDA records list 15 510(k) clearances for Merz North America, Inc., from to . As of , FDA records show no recalls naming K192185.

Clearance record

Decision date
Received
(58 days to decision)
Product code
OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Regulation
21 CFR 878.4790
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ulthera, Inc. 1840 S. Stapley Dr., Mesa AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUP

Trailing 12 months

FDA records hold no clearances under product code OUP in the trailing twelve months.

FDA records show no clearances under product code OUP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260