Solea

FDA UDI

Class II (US FDA UDI)

by Convergent Dental

Identity

Trade Name: Solea FDA UDI
Generic Name: Dental carbon dioxide laser system FDA UDI
Device Name: The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to ablate hard tissue or cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.3 µm to safely and effectively perform restorative and preventative dental procedures requiring ablation, incision, excision, vaporization, coagulation and hemostasis. FDA UDI
Model / Reference: Model 3.0 FDA UDI
Description: The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to ablate hard tissue or cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.3 µm to safely and effectively perform restorative and preventative dental procedures requiring ablation, incision, excision, vaporization, coagulation and hemostasis. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850634007018 FDA UDI
510(k) Number: K151306 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dental carbon dioxide laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental carbon dioxide laser system

Solea by Convergent Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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DENTA II — Lutronic Corporation · Class II
Solea — CONVERGENT DENTAL · Class II

Cleared under the same submission

K151306 also covers:

Solea — CONVERGENT DENTAL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Convergent Dental

Sources (1)

FDA UDI 9029f7fc-c85d-4b59-84c4-0409194f4b07 35 fields · synced Jun 8, 2026