Solea Model 3.0

• FDA 510(k) K151306 decided 23 Sep 2015 Active
• FDA GUDID UDI-DI 00850634007018 listed 11 Jun 2018 Listed

1. 23 Sep 2015 Cleared FDA 510(k) K151306
2. 11 Jun 2018 Listed FDA GUDID 00850634007018

Trade name

Solea

Generic name

Dental carbon dioxide laser system

Model / reference

Model 3.0

Primary DI / UDI-DI

00850634007018

510(k) Number

K151306 ↗

FDA product code

GEX

GMDN term

Dental carbon dioxide laser system

Device class

Class II

Regulation number

878.4810

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Dental carbon dioxide laser system

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• Solea Model 2.0

  Class II

  FDA 510(k) K151306 Active Cleared 23 Sep 2015 GUDID on market

• Solea

  Class II

  FDA 510(k) K130420 Active Cleared 12 Jul 2013

• Solea Open recall

  Class II

  FDA 510(k) K221761 Active Cleared 14 Sep 2022

• Solea

  Class II

  FDA 510(k) K151306 Active Cleared 23 Sep 2015

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