Solea Model 2.0

• FDA 510(k) K151306 decided 23 Sep 2015 Active
• FDA GUDID UDI-DI 00850634007001 listed 16 Sep 2016 Listed

1. 23 Sep 2015 Cleared FDA 510(k) K151306
2. 16 Sep 2016 Listed FDA GUDID 00850634007001

Trade name

Solea

Generic name

Dental carbon dioxide laser system

Model / reference

Model 2.0

Primary DI / UDI-DI

00850634007001

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

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

• WAVELIGHT FS200 PATIENT INTERFACE 1505 by Alcon Research, Ltd.
• Laser Treatment System, Model: NYX and Grace by Canadian Pioneer Medical Technology Corporation
• UNICA 315 M CO2 SURGICAL LASER SYSTEM by Reliant Technologies, Inc.
• TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER by Lumen Development and Manufacturing, Inc.
• DENTAL LASER FIBER SYSTEM by Incisive Technologies, Inc.
• PICOSURE WORKSTATION by Cynosure, LLC
• MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM by Biolitec Medical Devices, Inc.
• MULTILASE 2100 A by Teknomed, Inc.
• SL-100 ND:YAG LASER FOR GYNECOLOGY USE by MEDICAL ENERGY, INC.
• DEKA SMARTXIDE TOUCH by El.En Electronic Engineering Spa

• Solea Model 3.0

  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

See all devices from Convergent Dental →