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510(k) Data Aggregation

K Number

Device Name

ULTHERA SYSTEM, MODEL 8850-0001

Manufacturer

Date Cleared

2009-09-11

(518 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

ULTHERA SYSTEM, MODEL 8850-0001

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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