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FDA PRODUCT CODE · CLASS II

OHV — Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4590
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K260618Ulthera, Inc. · 510k2026-05-21
K250418Ulthera, Inc. · 510k2025-05-13
K243035Ulthera, Inc. · 510k2025-02-24

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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