SOLEA

K130420 · Convergent Dental, Inc. · GEX · Jul 12, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130420
• Device Name: SOLEA
• Applicant: Convergent Dental, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Solea system is indicated for the following: - Ablation of hard tissue for caries removal and cavity preparation. . - Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity. .

Device Story

Solea is a mobile, cart-based CO2 dental laser (9.25µm wavelength) used by dentists for hard and soft tissue procedures. It delivers pulsed laser energy via an articulating arm to perform ablation, incision, excision, vaporization, coagulation, and hemostasis. The system features a user interface with a material selection icon (enamel, dentin, soft tissue) to adjust fluence and irradiation settings. Used in dental offices, the device allows clinicians to perform conservative cavity preparations and various soft tissue surgeries. The laser's thermal effects on tissue are controlled to ensure safety, with clinical benefits including reduced patient discomfort and efficient tissue management. Healthcare providers operate the device directly, using the output to replace or augment traditional mechanical drills and scalpels.

Clinical Evidence

In-vivo study at UCSF School of Dentistry evaluated pulpal effects of 9.3µm CO2 laser enamel ablation. Histological examination of pulp post-extraction showed no deleterious effects; no pain or discomfort reported by test subjects. Bench testing confirmed hard tissue thermal effects are equivalent to predicate systems.

Technological Characteristics

CO2 laser (9.25µm); Class IV; pulsed ablation mode; articulating arm beam delivery. Fluence: 0.01-0.3 J/mm² (hard tissue), 0.1-2 J/mm² (soft tissue). Irradiance: 2-264 W/mm² (hard tissue), 2-170 W/mm² (soft tissue). Repetition rate: 1000-2200 Hz (hard tissue), 20-100 Hz (soft tissue). Sterilization: Steam autoclave (ANSI/AAMI ST79). Electrical safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.

Indications for Use

Indicated for adult and pediatric patients requiring hard tissue ablation for caries removal and cavity preparation, or soft tissue incision, excision, vaporization, coagulation, and hemostasis in the oral cavity.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Solea (K123494)
• Waterlase MD (K091746)
• LightWalker Laser System (K101817)

Submission Summary (Full Text)

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Convergent Dental, Inc. Traditional 510(k) Premarket Submission Solea

# JUL 1 2 2013

### Section 5 – 510(k) Summary for Solea

### 1. Submission Sponsor

Convergent Dental, Inc. 2 Vision Drive Natick, MA 01760 USA Phone: [phone] Contact: Jon Quillard, VP of Regulatory Affairs

### 2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400, Austin, TX 78701 Cell Phone: Office Phone: [phone] Fax: [phone] Contact: Carrie Hetrick, Senior Consultant Email: [e-mail]

#### Date Prepared 3.

June 28, 2013

### 4. Device Name

Trade/Proprietary Name: Solea Common/Usual Name: CO2 laser Classification Name: Laser surgical instrument for use in general and plastic surgery and dermatology Classification Regulation: 878.4810 Classification Panel: General and Plastic Surgery Product Code: GEX Device Class: Ik

FDA Establishment Registration #: 10043517

### 5. Predicate Devices

Convergent Dental, Inc., Solea, 510(k) Number: K123494 Biolase Technology, Inc., Waterlase MD, 510(k) Number: K091746 Fotona d.d., LightWalker Laser System, 510(k) Number: K101817

{1}------------------------------------------------

Convergent Dental, Inc. Traditional 510(k) Premarket Submission Solea

#### 6. Device Description

:

The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494). The only changes from the previously cleared device are the addition of the hard tissue indications, which combines minor software and graphic changes that will be added to the Solea system. This software change does not change the operational software, but adds a material selection icon on the home screen to include enamel, dentin, and soft tissue. The enamel and dentin settings have substantially equivalent fluence and irradiation as the hard tissue predicate devices. There are no other hardware or software changes to the Solea system device pending herein when compared to the device cleared under K123494.

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to cut and ablate hard tissue and to cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.25pm to safely and effectively perform ablation, incision, excision, vaporization, coagulation and hemostasis procedures.

### 7. Intended Use

The Solea system is indicated for the following:

- Ablation of hard tissue for caries removal and cavity preparation. .
- Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity. .

### 8. Technological Characteristics and Substantial Equivalence

The following table compares the Convergent Dental, Inc. Solea system to the Biolase Technology Inc. Waterlase MD, Fotona d.d. LightWalker Laser System Family with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence for intended uses.

The Solea system is substantially equivalent for hard tissue interms of fluence, irradiance, measured comparative performance data, and all features that affect safety or effectiveness to the Biolase Technology, Inc. Waterlase MD (K091746) and the Fotona d.d., LightWalker Laser System (K101817). For soft tissue indications, the Solea system included herein is the same device that was previously cleared by the FDA as the Convergent Dental, Inc. Solea system (K123494).

| | Convergent Dental, Inc. | Convergent Dental, Inc. | Biolase Technology, Inc. | Fotona d.d. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Solea | Solea | Waterlase® MD | LightWalker Laser System Family |
| 510(k) Number | K130420 | K123494 | K091746 | K101817 |
| Common name | Powered Laser surgical instrument | Powered Laser surgical instrument | Powered Laser surgical instrument | Powered Laser surgical instrument |
| FDA Classification Names | Powered Laser surgical instrument | Powered Laser surgical instrument | Powered Laser surgical instrument<br>Drill, bone, powered | Powered Laser surgical instrument |
| | Convergent Dental,<br>Inc. | Convergent Dental,<br>Inc. | Biolase Technology,<br>Inc.<br>System, Dental,<br>Hydrokinetic, Carries<br>Removal & Cavity<br>Preparation | Fotona d.d. |
| FDA<br>Classification<br>codes | GEX, a Class II device | GEX, a Class II device | GEX, MXF, DZI, a<br>Class II device | GEX, a Class II device |
| Predicates<br>cited | K091746, K101817<br>for hard tissue<br>indications<br>K123494 for soft<br>tissue indications | K091320 for soft<br>tissue indications | K031140, K071363,<br>K090181 for hard<br>tissue indications | K093162 for hard<br>tissue indications |
| Target User | General practitioner<br>dentists and<br>specialists | General practitioner<br>dentists and<br>specialists | General practitioner<br>dentists and<br>specialists | General practitioner<br>dentists and<br>specialists |
| Indications<br>for Use | The Solea system is<br>indicated for the<br>following:<br>- Ablation of hard<br>tissue for caries<br>removal and<br>cavity<br>preparation.<br>- Incision,<br>Excision,<br>Vaporization,<br>Coagulation and<br>Hemostasis of<br>soft tissue in the<br>oral cavity. | The Solea system is<br>indicated for the<br>following:<br>- Incision,<br>Excision,<br>Vaporization,<br>Coagulation and<br>Hemostasis of<br>soft tissue in the<br>oral cavity. | General Indications*<br>Class I, II, III, IV and V<br>cavity preparation<br>Caries removal<br>Hard tissue surface<br>roughening or<br>etching<br>Enameloplasty,<br>excavation of pits<br>and fissures for<br>placement of<br>sealants*<br>* For use on adult<br>and pediatric<br>patients<br>Root Canal Hard<br>Tissue Indications<br>Tooth preparation to<br>obtain access to root<br>canal<br>Root canal<br>preparation including<br>enlargement<br>Root canal<br>debridement and<br>cleaning<br>Root Canal<br>Disinfection<br>Laser root canal<br>disinfection after<br>endodontic<br>instrumentation<br>Bone Surgical | The LightWalker<br>Er:YAG laser, and its<br>accessories, are<br>intended for use in<br>dentistry,<br>dermatology and<br>other surgical areas<br>in the following<br>procedures:<br>In dentistry, for:<br>- Intra-oral soft<br>tissue surgery<br>(incision,<br>excision,<br>ablation<br>coagulation)<br>- Leukoplakia<br>- Pulpotomy as<br>adjunct to root<br>canal<br>retreatment<br>- Pulp extirpation<br>- Removal of<br>fibromae<br>- Removal of<br>granulated tissue<br>- Caries removal,<br>cavity<br>preparation, |
| Convergent Dental, | Convergent Dental, | Biolase Technology, | Fotona d.d. | |
| Inc. | Inc. | Inc. | | |
| | | Indications | roughening | |
| | | Cutting, shaving, | - Sulcular<br>debridement | |
| | | contouring and | | |
| | | resection of oral | - Tooth<br>preparation to | |
| | | osseous tissues | obtain access to | |
| | | (bone) | root canal, root | |
| | | Osteotomy | canal | |
| | | Endodontic Surgery | debridement | |
| | | (Root Amputation) | and cleaning, | |
| | | Indications | root | |
| | | Flap preparation - | canal | |
| | | incision of soft tissue | preparation | |
| | | to prepare a flap and | including | |
| | | expose the bone. | enlargement | |
| | | Cutting bone to | - Cutting, shaving, | |
| | | prepare a window | contouring and | |
| | | access to the apex | resection of oral | |
| | | (apices) of the | osseous tissue | |
| | | root(s). | (bone) | |
| | | Apicoectomy - | - Osteotomy, | |
| | | amputation of the | osseous crown | |
| | | root end. | lengthening, | |
| | | Root end preparation | osteoplasty | |
| | | for retrofill amalgam | - Apicectomy | |
| | | or composite. | surgery. | |
| | | Removal of |…