Product code OUP— General, Plastic Surgery

“Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.”

FDA has cleared 9 devices under product code OUP between 2013 and 2023, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20231 clearance
• 20221 clearance
• 20211 clearance
• 20191 clearance
• 20162 clearances
• 20151 clearance
• 20141 clearance
• 20131 clearance

• Ulthera, Inc.4 clearances
• Revelle Aesthetics, Inc.2 clearances
• Cabochon Aesthetics, Inc.2 clearances
• Nc8, Inc.1 clearance

• K232153 — AvéliRevelle Aesthetics, Inc.·2023-08-18
• K221336 — AvéliRevelle Aesthetics, Inc.·2022-08-05
• K212399 — AveliNc8, Inc.·2021-10-22
• K192185 — The Cellfina SystemUlthera, Inc.·2019-10-09
• K161885 — The Cellfina SystemUlthera, Inc.·2016-10-05
• K153677 — The Cellfina SystemUlthera, Inc.·2016-02-25
• K150505 — Cellfina SystemUlthera, Inc.·2015-07-29
• K134010 — CABOCHON SYSTEMCabochon Aesthetics, Inc.·2014-04-14
• DEN110004 — CABOCHON SYSTEMCabochon Aesthetics, Inc.·2013-07-12