Solea

510(k) Number

K151306 ↗

FDA product code

GEX

Device class

Class II

Regulation

21 CFR Part 878.4810

Advisory committee

General, Plastic Surgery

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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

• XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 by Xanar, Inc.
• SMARTXIDE 50 HS/MS by El.En Electronic Engineering Spa
• SPECULUM SMOKE EVACUATOR TUBING by I.C. Medical, Inc.
• Medical Picosecond ND: YAG Laser System (PZ-6) by Zhengzhou PZ Laser Slim Technology Co., Ltd.
• Syneron CO2RE System by Syneron Candela Corporation
• COHERENT HOLMIUM:YAG SURGICAL LASER by Coherent Medical Division
• VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM by BIOTEX, INC.
• SMARTLIPO ND:YAG LASER by Cynosure, LLC
• Fraxis Duo 25Pin Needle Tip MTR-AC-25 by CLASSYS Inc.
• Picosecond Nd:YAG Laser Systems (Model HS-298) by Shanghai Apolo Medical Technology Co., Ltd

• Solea Model 3.0

  Class II

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

• 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

See all devices from Convergent Dental →