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

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

21 CFR 878.4590 / General, Plastic Surgery
FDA source (opens on fda.gov)

OHV is the FDA product code for Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption, a class II device type, regulated under 21 CFR 878.4590. FDA's definition for this code reads: "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". As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OHV
Device name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
FDA definition
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.
Regulation
21 CFR 878.4590
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
30
Ingested recalls
1

Clearances, product code OHV

By decision year
30 clearances under product code OHV with a decision year between 2009 and 2026, 2023 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code OHV by decision year
YearClearances
20091
20112
20122
20131
20143
20163
20171
20181
20192
20211
20221
20237
20242
20252
20261

Applicants with the most clearances

Product code OHV
Applicants holding the most 510(k) clearances under product code OHV
ApplicantClearances
Merz North America, Inc.10
Sofwave Medical Ltd.9
Syneron Medical, Ltd.6
Medicis Technologies Corporation2
Beshape Technologies, Ltd.1
Classys Inc1
Jeisys Medical Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order