← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K130420 # SOLEA (K130420) _Convergent Dental, Inc. · GEX · Jul 12, 2013 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K130420 ## Device Facts - **Applicant:** Convergent Dental, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Jul 12, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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. ## Regulatory 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](/device/K123494.md)) - Waterlase MD ([K091746](/device/K091746.md)) - LightWalker Laser System ([K101817](/device/K101817.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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: (508) 500-5656 Contact: Jon Quillard, VP of Regulatory Affairs ### 2. Submission Correspondent Emergo Group 816 Congress Avenue, Suite 1400, Austin, TX 78701 Cell Phone: Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant Email: project.management@emergogroup.com #### 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
Drill, bone, powered | Powered Laser surgical instrument | | | Convergent Dental,
Inc. | Convergent Dental,
Inc. | Biolase Technology,
Inc.
System, Dental,
Hydrokinetic, Carries
Removal & Cavity
Preparation | Fotona d.d. | | FDA
Classification
codes | GEX, a Class II device | GEX, a Class II device | GEX, MXF, DZI, a
Class II device | GEX, a Class II device | | Predicates
cited | K091746, K101817
for hard tissue
indications
K123494 for soft
tissue indications | K091320 for soft
tissue indications | K031140, K071363,
K090181 for hard
tissue indications | K093162 for hard
tissue indications | | Target User | General practitioner
dentists and
specialists | General practitioner
dentists and
specialists | General practitioner
dentists and
specialists | General practitioner
dentists and
specialists | | Indications
for 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. | The Solea system is
indicated for the
following:
- Incision,
Excision,
Vaporization,
Coagulation and
Hemostasis of
soft tissue in the
oral cavity. | General Indications*
Class I, II, III, IV and V
cavity preparation
Caries removal
Hard tissue surface
roughening or
etching
Enameloplasty,
excavation of pits
and fissures for
placement of
sealants*
* For use on adult
and pediatric
patients
Root Canal Hard
Tissue Indications
Tooth preparation to
obtain access to root
canal
Root canal
preparation including
enlargement
Root canal
debridement and
cleaning
Root Canal
Disinfection
Laser root canal
disinfection after
endodontic
instrumentation
Bone Surgical | The LightWalker
Er:YAG laser, and its
accessories, are
intended for use in
dentistry,
dermatology and
other surgical areas
in the following
procedures:
In dentistry, for:
- Intra-oral soft
tissue surgery
(incision,
excision,
ablation
coagulation)
- Leukoplakia
- Pulpotomy as
adjunct to root
canal
retreatment
- Pulp extirpation
- Removal of
fibromae
- Removal of
granulated tissue
- Caries removal,
cavity
preparation, | | Convergent Dental, | Convergent Dental, | Biolase Technology, | Fotona d.d. | | | Inc. | Inc. | Inc. | | | | | | Indications | roughening | | | | | Cutting, shaving, | - Sulcular
debridement | | | | | contouring and | | | | | | resection of oral | - Tooth
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 |… --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K130420](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K130420) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com