510(k) clearances

Ulthera® System

Ulthera, Inc. · General, Plastic Surgery

K243035Substantially EquivalentTraditionalOHV
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Third party flag
N
City
Raleigh
Advisory committee description
General, Plastic Surgery
Address 1
6501 Six Forks Rd.
Statement or summary
Summary
Product code
OHV
Zip code
27615
Applicant
Ulthera, Inc.
Decision date
2025-02-24
Decision code
SESE
Country code
US
Device name
Ulthera® System
Advisory committee
SU
Contact
Scott Jewett
K number
K243035
State
NC
Date received
2024-09-27
Review advisory committee
SU
Postal code
27615
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Medical specialty description
General, Plastic Surgery
Regulation number
878.4590
Device class
2
Registration number
2133641, 3009736547, 1012187, 3011423170, 3005646850, 3033715699, 3012259264, 3027725665, 3013840437, 2030624, 1313525, 3013917867, 1725006, 3006985163, 3005238200, 3015889734, 3006807694, 1054713
FEI number
3000203466, 3009736547, 1012187, 3005646850, 1317628, 3033715699, 3012259264, 3027725665, 3004106598, 3013840437, 3013917867, 3000206435, 3003258642, 1000114111, 3006985163, 3005238200, 3015889734, 3006807694
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.