← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K151306 # Solea (K151306) _Convergent Dental, Inc. · GEX · Sep 23, 2015 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K151306 ## Device Facts - **Applicant:** Convergent Dental, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Sep 23, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## 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 - Cutting, shaving, contouring and resection of oral osseous tissue (bone) ## Device Story Solea is a mobile, cart-based dental laser system using 9.25μm CO2 laser energy to perform hard tissue, soft tissue, and osseous tissue procedures. Operated by general practitioner dentists and specialists in a dental office, the device uses an articulating arm for beam delivery. The system functions via pulsed laser energy for ablation and continuous wave for aiming. It provides clinicians with a tool for precise tissue management, replacing traditional mechanical drills or scalpels in various oral procedures. The device benefits patients by enabling minimally invasive procedures with potential for reduced bleeding and improved healing. No software or hardware changes were made for this specific clearance; it leverages previously cleared settings for hard and soft tissue, with osseous tissue settings demonstrated to be equivalent to predicate laser systems. ## Clinical Evidence No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), laser safety (IEC 60601-2-22, IEC 60825-1), sterilization validation (AAMI TIR12, ANSI/AAMI ST79), and usability testing (IEC 62366). Bench testing confirmed thermal effects on hard tissue are equivalent to predicate devices. ## Technological Characteristics Mobile, cart-based CO2 laser (9.25μm wavelength). Class 4 (IV) laser product. Beam delivery via articulating arm (free space). Operating modes: pulsed (ablation) and continuous (aiming). Sterilization via steam autoclave (handpieces). EMC compliance per CISPR 11 Class A. ## 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)) - Solea ([K130420](/device/K130420.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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Convergent Dental Incorporated % Ms. Carrie Hetrick Emergo 816 Congress Avenue, Suite 1400 Austin, Texas 78701 September 23, 2015 Re: K151306 Trade/Device Name: Solea Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: May 14, 2015 Received: May 18, 2015 Dear Ms. Hetrick: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Joshua C. Nipper -S For I Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151306 Device Name Solea Indications for Use (Describe) 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 - Cutting, shaving, contouring and resection of oral osseous tissue (bone) Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary for ## Solea ### 1. Submission Sponsor Convergent Dental, Inc. 2 Vision Drive Natick, MA 01760 USA Phone: (508) 500.5656 Contact: Mike Manor, Director QA/RA ### 2. Submission Correspondent Emergo 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com ### 3. Date Prepared August 14, 2015 ### 4. Device Identification | Trade/Proprietary Name: | Solea | |----------------------------|-------------------------------------------------------------------------------------| | Common/Usual Name: | Powered laser surgical instrument | | Classification Name: | Laser surgical instrument for use in general and plastic surgery
and dermatology | | Classification Regulation: | 21 CFR §878.4810 | | Product Code: | GEX | | Device Class: | Class II | | Classification Panel: | General and Plastic Surgery | ### 5. Legally Marketed Predicate Device(s) Convergent Dental, Inc., Solea, 510(k) Numbers: K123494, K130420 Biolase Technology, Inc., Waterlase MD, 510(k) Number: K091746 Fotona d.d., LightWalker Laser System, 510(k) Number: K101817 ### 6. Device Description {4}------------------------------------------------ The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494) and hard tissue indications (K130420). The only changes from the previously cleared device are the addition of the osseous tissue indications. There have been no software changes or graphic changes to the Solea system. The osseous tissue settings are the same as the previously cleared device (K130420). The osseous 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 and K130420. 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 9.25μm to safely and effectively perform ablation, incision, excision, vaporization, coagulation and hemostasis procedures. ### 7. Indication for Use Statement 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 - -Cutting, shaving, contouring and resection of oral osseous tissue (bone) ### 8. Substantial Equivalence Discussion The following table compares the Solea to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. The Convergent Dental, Inc. Solea system is a dental laser previously cleared by the FDA for hard tissue indications (K130420) and soft tissue indications (123494). The Solea system included herein is the same device that was previously cleared by the FDA in K130420 (Solea, expanded hard tissue indications) and K123494 (Solea®, indications for soft tissue indications). There are no unique applications, materials or specifications presented herein. All the presented indications for use retain the same meaning as their equivalent indications cleared by the FDA. The subject Solea system is substantially equivalent to the Biolase Technology, Inc. Waterlase MD (K091746) and the Fotona d.d., LightWalker Laser System (K101817) for the osseous tissue indications in terms of fluence, measured comparative performance data, and all features that affect safety or effectiveness. The following table compares the subject Convergent Dental, Inc. Solea system to the Biolase Technology Inc. Waterlase MD, Fotona d.d. LightWalker Laser System Family, and the previously cleared Solea systems, 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. {5}------------------------------------------------ | | Convergent
Dental, Inc. | Convergent
Dental, Inc. | Convergent
Dental, Inc. | Biolase
Technology, Inc. | Fotona d.d. | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Solea | Solea | Solea | Waterlase® MD | LightWalker
Laser System
Family | | 510(k)
Number | K152306 | K130420 | K123494 | K091746 | K101817 | | Common
name | Powered
Laser surgical
instrument | 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 | Powered Laser
surgical
instrument
Drill, bone,
powered
System, Dental,
Hydrokinetic,
Carries Removal
& Cavity
Preparation | Powered Laser
surgical
instrument | | FDA
Classification
codes | GEX, a Class
II device | GEX, a Class
II device | GEX, a Class II
device | GEX, MXF, DZI, a
Class II device | GEX, a Class II
device | | Predicates
cited | K130420 and
K123494 for
hard and soft
tissue
indications
K091746,
K101817 for
osseous
tissue
indications | 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 | 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, | The Solea
system is
indicated for
the
following:
- Ablation
of hard
tissue
for
caries
removal
and
cavity
preparation.
- Incision, | The Solea
system is
indicated for
the following:
- Incision,
- Excision,
- Vaporization,
- Coagulation
and
- Hemostas
is 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 | 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, | | Convergent | Convergent | Convergent | Biolase | Fotona d.d. | | | Dental, Inc. | Dental, Inc. | Dental, Inc. | Technology, Inc. | | | | Vaporiza | Vaporiza | | pediatric | ablation | | | tion, | tion, | | patients | coagulation | | | Coagulat | Coagulat | | Root Canal Hard | ) | | | ion and | ion and | | Tissue | Leukoplaki | | | Hemosta | Hemosta | | Indications | a | | | sis of | sis of | | Tooth | - Pulpotomy | | | soft | soft | | preparation to | as adjunct | | | tissue in | tissue in | | obtain access to | to root | | | the oral | the oral | | root canal | canal | | | cavity | cavity. | | Root canal | retreatmen | | | - Cutting, | | | preparation | t | | | shaving, | | | including | - Pulp | | | contouri | | | enlargement | extirpation | | | ng and | | | Root canal | - Removal of | | | resectio | | | debridement | fibroma | | | n of oral | | | and cleaning | - Removal of | | | osseous | | | Root Canal | granulated | | | tissue | | | Disinfection | tissue | | | (bone) | | | Laser root canal | - Caries | | | | | | disinfection after | removal, | | | | | | endodontic | cavity | | | | | | instrumentation | preparatio | | | | | | Bone Surgical | n, enamel | | | | | | Indications | roughening | | | | | | Cutting, shaving, | - Sulcular | | | | | | contouring and | debrideme | | | | | | resection of oral | nt | | | | | | osseous tissues… --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K151306](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K151306) **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