Ulthera System

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Ulthera, Inc

The following data is part of a premarket notification filed by Ulthera, Inc with the FDA for Ulthera System.

Pre-market Notification Details

Device IDK180623
510k NumberK180623
Device Name:Ulthera System
ClassificationFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant Ulthera, Inc 1840 South Stapley Drive Suite 200 Mesa,  AZ  85204
ContactJessica Newhard
CorrespondentSteve Kachelmeyer
Ulthera, Inc 1840 South Stapley Drive Suite 200 Mesa,  AZ  85204
Product CodeOHV  
CFR Regulation Number878.4590 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-09
Decision Date2018-05-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840763101152 K180623 000

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