Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on laser technology and software changes for material selection, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is used for medical procedures like ablation, incision, excision, vaporization, coagulation, and hemostasis of tissues, which are therapeutic actions.

Diagnostic

No

The Solea system is described as a dental laser device used for ablation, incision, excision, vaporization, coagulation, and hemostasis of hard and soft tissues in the oral cavity. Its intended use is for treatment procedures, not for identifying or diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it 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." This indicates it is a physical hardware device, not software only. The software changes mentioned are additions to this existing hardware system.

IVD (In Vitro Diagnostic)

Based on the provided information, the Solea system is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
The Solea system is a dental laser used for directly treating tissues within the oral cavity (ablation, incision, excision, etc.). It operates on the patient's body, not on a sample taken from the patient.

The description clearly indicates it's a therapeutic device used for surgical procedures in the mouth.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

General practitioner dentists and specialists

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:

Electrical Safety Testing: The system passed electrical safety testing in accordance with requirements for IEC 60601-1 medical electrical equipment.
Electromagnetic Compatibility: The system passed electromagnetic compatibility (EMC) testing to meet requirements for IEC 60601-1-2 medical electrical equipment.
Laser Safety: The system passed particular requirements for IEC 60601-2-22 and IEC 60825-1 the safety of diagnostic and therapeutic laser equipment.
Cleaning and Sterilization: The handpieces of the Solea system passed cleaning and sterilization validations for reusable medical devices based on the overkill approach to demonstrate sterilization cycle lethality as described in AAMI TIR12 to achieve a Sterility Assurance Level (SAL) of at least 10-6. The Solea system handpieces are designed for sterilization by exposure to moist heat under conventional autoclave cycles qualified to ANSI/AAMI ST79.
Software: Verification testing was conducted on the Solea software. All tests were completed successfully with respect to stated pass/fail criteria thereby deeming the device and software appropriate for its intended use.
Usability: Usability testing was conducted on the Solea system. During the usability evaluation, dentists used the system to perform procedures on simulated tissues in a laboratory environment that replicates the intended deployment environment of the dental office. Based on the participant feedback and ratings of usability of the Solea system, all of the acceptance criteria for the user design validation have been met for the intended use.
Bench Testing: Solea Hard Tissue Testing: Performance data was collected from Bench Testing for hard tissue. Results show that hard tissue thermal effects are equivalent. The results show substantially equivalent results for the Solea system and the two predicate systems.

Clinical Testing:

Study type: In-vivo study
Data source: UCSF School of Dentistry
Key results: The study evaluated the pulpal effects of enamel ablation using a pulsed CO2 laser at a wavelength of 9.3μm. Histological examination of pulp immediately after extraction showed no deleterious effects on pulpal tissues and none of the test-subjects felt pain or discomfort after the procedure. The results show that the technology of the Solea system is safe for the intended uses.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123494, K091746, K101817

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

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 | | |
| | | pathological tissues | Removal of | |
| | | (i.e., cysts, neoplasm | subgingival calculi in | |
| | | or abscess) and | periodontal pockets | |
| | | hyperplastic tissues | with periodontitis by | |
| | | (i.e., granulation | closed or open | |
| | | tissue) from around | curettage | |
| | | the apex | | |
| | | NOTE: Any tissue | | |
| | | growth (i.e., cyst, | | |
| | | neoplasm or other | | |
| | | lesions) must be | | |
| | | submitted to a | | |
| | | qualified laboratory | | |
| | | for histopathological | | |
| | | evaluation. | | |
| | | Soft Tissue | | |
| | | Indications including | | |
| | | Pulpal Tissues* | | |
| | | Incision, excision, | | |
| | | vaporization, | | |
| | | ablation and | | |
| | | coagulation of oral | | |
| | | soft tissues | | |
| Convergent Dental, | Convergent Dental, | Biolase Technology, | Fotona d.d. | |
| Inc. | Inc. | Inc. | | |
| | | including: | | |
| | | Excisional and | | |
| | | incisional biopsies | | |
| | | Exposure of | | |
| | | unerupted teeth | | |
| | | Fibroma removal | | |
| | | Flap preparation - | | |
| | | incision of soft tissue | | |
| | | to prepare a flap and | | |
| | | expose the bone. | | |
| | | Flap preparation - | | |
| | | incision of soft tissue | | |
| | | to prepare a flap and | | |
| | | expose unerupted | | |
| | | teeth (hard and soft | | |
| | | tissue impactions) | | |
| | | Frenectomy and | | |
| | | frenotomy | | |
| | | Gingival troughing | | |
| | | for crown | | |
| | | impressions | | |
| | | Gingivectomy | | |
| | | Gingival incision and | | |
| | | excision | | |
| | | Hemostasis | | |
| | | Implant recovery | | |
| | | Incision and drainage | | |
| | | of abscesses | | |
| | | Laser soft tissue | | |
| | | curettage of the | | |
| | | post-extraction tooth | | |
| | | sockets and the | | |
| | | periapical area | | |
| | | during apical surgery | | |
| | | Leukoplakia | | |
| | | Operculectomy | | |
| | | Oral papillectomies | | |
| | | Pulpotomy | | |
| | | Pulp extirpation | | |
| | | Pulpotomy as an | | |
| | | adjunct to root canal | | |
| | | therapy | | |
| | | Root canal | | |
| | | debridement and | | |
| | | cleaning | | |
| | | Reduction of gingival | | |
| | | hypertrophy | | |
| | | Removal of | | |
| | | pathological tissues | | |
| | | | | |
| Convergent Dental, | Convergent Dental, | Biolase Technology, | Fotona d.d. | |
| Inc. | Inc. | Inc. | | |
| | | (i.e., cysts, neoplasm
or abscess) and
hyperplastic tissues | | |
| | | (i.e., granulation
tissue) from around
the apex | | |
| | | NOTE: Any tissue
growth (i.e., cyst,
neoplasm or other
lesions) must be
submitted to a
qualified laboratory
for histopathological
evaluation. | | |
| | | Soft tissue crown
lengthening | | |
| | | Treatment of canker
sores, herpetic and
aphthous ulcers of
the oral mucosa | | |
| | | Vestibuloplasty | | |
| | | Laser Periodontal
Procedures | | |
| | | Full thickness flap | | |
| | | Partial thickness flap | | |
| | | Split thickness flap | | |
| | | Laser soft tissue
curettage | | |
| | | Laser removal of
diseased, infected,
inflamed and
necrosed soft tissue
within the
periodontal pocket | | |
| | | Removal of highly
inflamed edematous
tissue affected by
bacteria penetration
of the pocket lining
junctional epithelium | | |
| | | Removal of
granulation tissue
from bony defects | | |
| | | Sulcular debridement
(removal of diseased,
infected, inflamed or
necrosed soft tissue
in the periodontal | | |
| | Convergent Dental,
Inc. | Convergent Dental,
Inc. | Biolase Technology,
Inc. | Fotona d.d. |
| | clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
Osseous crown lengthening
Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage. | | | |
| Laser
classification | Class 4 (IV) Laser
Product | Class 4 (IV) Laser
Product | Class 4 (IV) Laser
Product | Class 4 (IV) Laser
Product |
| Type of Laser | CO₂ (Carbon Dioxide) | CO₂ (Carbon Dioxide) | Er,Cr:YSGG (Erbium,
Chromium: Yttrium,
Scandium, Gallium,
Garnet) | Er:YAG (Erbium:
Yttrium, Aluminum,
Garnet)
Nd:YAG
(Neodymium-doped:
Yttrium, Aluminum,
Garnet) |
| Wavelength | 9.25µm (9250nm) | 9.25µm (9250nm) | 2.78µm (2780nm) | Er:YAG = 2.94µm
(2940nm) |
| | Convergent Dental,
Inc. | Convergent Dental,
Inc. | Biolase Technology,
Inc. | Fotona d.d. |
| | | | | Nd:YAG = $1.064µm$
( $1064nm$ ) |
| Fluence:
Energy per
mm² (per
pulse) | 0.01 - 0.3 J/mm²
(hard tissue)
0.1 – 2 J/mm² (soft
tissue) | 0.1 – 2 J/mm² (soft
tissue) | - | - |
| Repetition
Rate per
second (Hz) | 1000-2200 Hz (hard
tissue)
20-100 Hz (soft
tissue) | 20-100Hz (soft
tissue) | - | - |
| Irradiance:
Power per
mm² | 2 - 264 W/mm² (hard
tissue)
2-170 W/mm² (soft
tissue) | 2-170 W/mm² (soft
tissue) | - | - |
| Operating
Modes | Ablation laser: Pulsed
Aiming laser:
Continuous | Ablation laser: Pulsed
Aiming laser:
Continuous | Ablation laser: Pulsed
Aiming laser:
Continuous | Ablation laser: Pulsed
Aiming laser:
Continuous |
| Beam
Delivery | Articulating Arm
(Free Space) | Articulating Arm
(Free Space) | Fiber | Articulating Arm
(Free Space) |
| Sterilization
Method | Steam Autoclave | Steam Autoclave | Steam Autoclave | Steam Autoclave |
| RF emissions | CISPR 11 Group 1 | CISPR 11 Group 1 | CISPR 11 Group 1 | CISPR 11 Group 1 |
| EMC
compliance | CISPR 11 Class A | CISPR 11 Class A | CISPR 11 Class A | CISPR 11 Class A |

2

3

4

.

5

6

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

.

7

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

9. Non-Clinical Testing

The Solea system meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety. The results of the non-clinical testing confirm the output meets the design inputs and specifications. Bench testing was performed to demonstrate substantial equivalence to the predicate device in terms of safety and performance. The following non-clinical testing was performed:

Electrical Safety Testing: .

The system passed electrical safety testing in accordance with requirements for IEC 60601-1 medical electrical equipment.

Electromagnetic Compatibility: . The system passed electromagnetic compatibility (EMC) testing to meet requirements for IEC 60601-1-2 medical electrical equipment.
. Laser Safety: The system passed particular requirements for IEC 60601-2-22 and IEC 60825-1 the safety of diagnostic and therapeutic laser equipment.
Cleaning and Sterilization: .

8

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

The handpieces of the Solea system passed cleaning and sterilization validations for reusable medical devices based on the overkill approach to demonstrate sterilization cycle lethality as described in AAMI TIR12 to achieve a Sterility Assurance Level (SAL) of at least 10-6. The Solea system handpieces are designed for sterilization by exposure to moist heat under conventional autoclave cycles qualified to ANSI/AAMI ST79.

. Software:
Verification testing was conducted on the Solea software. All tests were completed successfully with respect to stated pass/fail criteria thereby deeming the device and software appropriate for its intended use.
. Usability:
Usability testing was conducted on the Solea system. During the usability evaluation, dentists used the system to perform procedures on simulated tissues in a laboratory environment that replicates the intended deployment environment of the dental office. Based on the participant feedback and ratings of usability of the Solea system, all of the acceptance criteria for the user design validation have been met for the intended use.
Bench Testing: Solea Hard Tissue Testing: .
Performance data was collected from Bench Testing for hard tissue. Results show that hard tissue thermal effects are equivalent. The results show substantially equivalent results for the Solea system and the two predicate systems.

10. Clinical Testing

An in-vivo study was conducted at the UCSF School of Dentistry to evaluate the pulpal effects of enamel ablation using a pulsed CO2 laser at a wavelength of 9.3μm. The fundamental science and design of the laser system used for this UCSF research is substantially equivalent to the Solea system. The purpose of the study was to determine if heat disposition in the tooth may have any detrimental pulpal effects under the conditions required for small conservative preparations confined to enamel. Histological examination of pulp immediately after extraction showed no deleterious effects on pulpal tissues and none of the test-subjects felt pain or discomfort after the procedure. The results show that the technology of the Solea system is safe for the intended uses.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The Solea device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between the Solea system and the predicate devices do not raise any questions regarding its safety and effectiveness. Performance testing and compliance with voluntary standards, demonstrate that the Solea system is substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, sterilization, biocompatibility, performance characteristics, and

9

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

intended use. Solea, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

10

Image /page/10/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human form or a caduceus-like design.

DEPARTMENT OF HEALTH & HUM AN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Cantrol Center - WO66-G609 Silver Spring, MD 20993-002

Convergent Dental, Inc. % Emergo Group, Inc. Ms. Carrie Hetrick, DDS 611 West 5th Street, Third Floor Austin, Texas 78701

July 12, 2013

Re: K130420

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 08, 2013 Received: May 09, 2013

Dear Dr. 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

11

Page 2 - Ms. Carrie Hetrick, DDS

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetw/ReportaProblem/deliault.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 Small Manufacturers, International and Consumer Assistance 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,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

12

Indications for Use Statement

510(k) Number (if known): K130420

Device Name: Solea

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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.07.12 08:49:51 -04'00'

(D:v:son Sign-Off) for MXI:1

Division of Surgical Devices K130420 510jkj Number

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