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

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Convergent Dental, Inc. Solea device, based on the provided text:

Important Note: The provided document is a 510(k) Premarket Submission for the Solea dental laser, specifically for the expansion of its indications to include hard tissue. The primary goal of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove absolute effectiveness or ideal performance against predefined, standalone acceptance criteria in the same way a new drug might. The "acceptance criteria" here are therefore inferred from the documentation's focus on demonstrating equivalence in safety and performance to predicates through various tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) submission)	Reported Device Performance
Electrical Safety (IEC 60601-1)	Passed electrical safety testing.
Electromagnetic Compatibility (IEC 60601-1-2)	Passed electromagnetic compatibility (EMC) testing.
Laser Safety (IEC 60601-2-22, IEC 60825-1)	Passed specified laser safety requirements.
Cleaning and Sterilization (AAMI TIR12, ANSI/AAMI ST79)	Handpieces passed cleaning and sterilization validations (overkill approach, SAL of at least 10-6).
Software Verification	All tests completed successfully with respect to stated pass/fail criteria, deeming software appropriate for intended use.
Usability (User Design Validation)	All acceptance criteria for user design validation met, based on participant feedback and ratings.
Hard Tissue Performance (Substantial Equivalence to Predicates)	Bench testing demonstrated that hard tissue thermal effects are equivalent to predicate devices, showing substantially equivalent results.
Pulpal Safety (for Small Conservative Preparations)	No deleterious effects on pulpal tissues observed immediately after extraction; no pain or discomfort reported by test subjects.

2. Sample Size Used for the Test Set and Data Provenance

Pulpal Safety Study (Clinical Testing):
- Sample Size: Not explicitly stated as a number of teeth or patients. The text mentions "none of the test-subjects felt pain or discomfort," implying a human subject study, but the specific number is not disclosed.
- Data Provenance: Prospective in-vivo study conducted at the UCSF School of Dentistry (United States).
Usability Testing:
- Sample Size: Not explicitly stated (e.g., number of dentists participating).
- Data Provenance: Conducted using "dentists... on simulated tissues in a laboratory environment that replicates the intended deployment environment of the dental office." This suggests a prospective simulation-based study.
Bench Testing (Hard Tissue Performance):
- Sample Size: Not explicitly stated (e.g., number of samples or tests).
- Data Provenance: Bench testing, which is generally laboratory-based (likely in the US, given the sponsor location).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Pulpal Safety Study: The text mentions "Histological examination of pulp immediately after extraction." While this implies expert pathological assessment, the number and specific qualifications of the experts (e.g., pathologists, oral surgeons) are not explicitly stated.
Usability Testing: "Participant feedback and ratings of usability" were used. The participants were "dentists," implying general practitioners or specialists. The number of dentists involved is not explicitly stated.
Bench Testing: The ground truth for performance was established by direct measurement and comparison to predicate devices, not by expert consensus on a test set in the traditional sense of diagnostic accuracy.

4. Adjudication Method for the Test Set

No information is provided about an explicit adjudication method (e.g., 2+1, 3+1 consensus) for any of the studies mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done. This device is a dental laser, not an AI diagnostic tool, so this type of study is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Solea system is a medical device (laser), not an algorithm or AI. The performance studies focus on the laser's physical effects and safety when operated by a human user.

7. The Type of Ground Truth Used

Pulpal Safety Study: Histological examination of pulpal tissues (pathology-based ground truth) and absence of pain/discomfort (patient outcome/symptom-based ground truth). Studies used "in-vivo" methods, implying actual biological response.
Usability Testing: Direct observation and subjective feedback/ratings from dentists.
Hard Tissue Bench Testing: Direct physical measurements of thermal effects and comparison to established predicate device performance.

8. The Sample Size for the Training Set

Not applicable. This device is a laser system, not an AI/machine learning algorithm that requires a training set in that context. The "training" for the device is its design and engineering based on known principles of laser physics and previous device clearances.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of AI/machine learning. The "ground truth" for the device's development and design would be established through scientific literature, engineering principles, and the performance characteristics of previously cleared predicate devices (K091746 and K101817 for hard tissue, K123494 for soft tissue). The submission explicitly states that the new hard tissue indications "combine minor software and graphic changes" and have "substantially equivalent fluence and irradiation as the hard tissue predicate devices." This indicates the design was guided by known safe and effective parameters from existing, cleared devices.

Summary

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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: (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

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

6. Device Description

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 instrumentDrill, bone, powered	Powered Laser surgical instrument
	Convergent Dental,Inc.	Convergent Dental,Inc.	Biolase Technology,Inc.System, Dental,Hydrokinetic, CarriesRemoval & CavityPreparation	Fotona d.d.
FDAClassificationcodes	GEX, a Class II device	GEX, a Class II device	GEX, MXF, DZI, aClass II device	GEX, a Class II device
Predicatescited	K091746, K101817for hard tissueindicationsK123494 for softtissue indications	K091320 for softtissue indications	K031140, K071363,K090181 for hardtissue indications	K093162 for hardtissue indications
Target User	General practitionerdentists andspecialists	General practitionerdentists andspecialists	General practitionerdentists andspecialists	General practitionerdentists andspecialists
Indicationsfor Use	The Solea system isindicated for thefollowing:- Ablation of hardtissue for cariesremoval andcavitypreparation.- Incision,Excision,Vaporization,Coagulation andHemostasis ofsoft tissue in theoral cavity.	The Solea system isindicated for thefollowing:- Incision,Excision,Vaporization,Coagulation andHemostasis ofsoft tissue in theoral cavity.	General IndicationsClass I, II, III, IV and Vcavity preparationCaries removalHard tissue surfaceroughening oretchingEnameloplasty,excavation of pitsand fissures forplacement ofsealants* For use on adultand pediatricpatientsRoot Canal HardTissue IndicationsTooth preparation toobtain access to rootcanalRoot canalpreparation includingenlargementRoot canaldebridement andcleaningRoot CanalDisinfectionLaser root canaldisinfection afterendodonticinstrumentationBone Surgical	The LightWalkerEr:YAG laser, and itsaccessories, areintended for use indentistry,dermatology andother surgical areasin the followingprocedures:In dentistry, for:- Intra-oral softtissue surgery(incision,excision,ablationcoagulation)- Leukoplakia- Pulpotomy asadjunct to rootcanalretreatment- Pulp extirpation- Removal offibromae- Removal ofgranulated tissue- Caries removal,cavitypreparation,
Convergent Dental,	Convergent Dental,	Biolase Technology,	Fotona d.d.
Inc.	Inc.	Inc.
		Indications	roughening
		Cutting, shaving,	- Sulculardebridement
		contouring and
		resection of oral	- Toothpreparation 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, neoplasmor abscess) andhyperplastic tissues
		(i.e., granulationtissue) from aroundthe apex
		NOTE: Any tissuegrowth (i.e., cyst,neoplasm or otherlesions) must besubmitted to aqualified laboratoryfor histopathologicalevaluation.
		Soft tissue crownlengthening
		Treatment of cankersores, herpetic andaphthous ulcers ofthe oral mucosa
		Vestibuloplasty
		Laser PeriodontalProcedures
		Full thickness flap
		Partial thickness flap
		Split thickness flap
		Laser soft tissuecurettage
		Laser removal ofdiseased, infected,inflamed andnecrosed soft tissuewithin theperiodontal pocket
		Removal of highlyinflamed edematoustissue affected bybacteria penetrationof the pocket liningjunctional epithelium
		Removal ofgranulation tissuefrom bony defects
		Sulcular debridement(removal of diseased,infected, inflamed ornecrosed soft tissuein 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 lengtheningLaser 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.
Laserclassification	Class 4 (IV) LaserProduct	Class 4 (IV) LaserProduct	Class 4 (IV) LaserProduct	Class 4 (IV) LaserProduct
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 permm² (perpulse)	0.01 - 0.3 J/mm²(hard tissue)0.1 – 2 J/mm² (softtissue)	0.1 – 2 J/mm² (softtissue)	-	-
RepetitionRate persecond (Hz)	1000-2200 Hz (hardtissue)20-100 Hz (softtissue)	20-100Hz (softtissue)	-	-
Irradiance:Power permm²	2 - 264 W/mm² (hardtissue)2-170 W/mm² (softtissue)	2-170 W/mm² (softtissue)	-	-
OperatingModes	Ablation laser: PulsedAiming laser:Continuous	Ablation laser: PulsedAiming laser:Continuous	Ablation laser: PulsedAiming laser:Continuous	Ablation laser: PulsedAiming laser:Continuous
BeamDelivery	Articulating Arm(Free Space)	Articulating Arm(Free Space)	Fiber	Articulating Arm(Free Space)
SterilizationMethod	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
EMCcompliance	CISPR 11 Class A	CISPR 11 Class A	CISPR 11 Class A	CISPR 11 Class A

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

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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: .

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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

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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.

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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

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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

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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✌son Sign-Off) for MXI:1

Division of Surgical Devices K130420 510jkj Number

Page 4 • 1

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.