Eu Mdr Eu Md Class 1 On The Market 🇺🇸 United States

ISOLAZ 2 TREATMENT TIP, ACNE, SMALL, 1 E

Solta Medical, Inc. · 🇺🇸 United States
Devices (same UDI-DI)
11
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
00816995020295
Basic UDI-DI Code
081699502B0008WJ
Reference
Z120615
Device Types
Single use
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
Solta Medical, Inc.

Additional Description

Treatment tips are intended for single patient use and come in three sizes: small, medium, and large. Prior to use, the size of the treatment tip is selected based on the size of the desired treatment area. Treatment tips are intended to be attached to the distal end of the Isolaz 2 handpiece and physically demark the treatment area. A vacuum is then pulled by the Isolaz 2 Cart, creating a seal with the surrounding skin during treatment. Treatment tips contain a borosilicate window which allows for intense pulsed light to pass from the flash lamp through the tip and onto the treatment area.

CND Nomenclature Codes

Code Description
Z120615 THERAPEUTIC LASERS

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The Basic UDI-DI associated with this device has 11 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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