Dental Soft Tissue Indications Including Pulpal Tissues*: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectorny, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia, Operculectormy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, and Vestibuloplasty. *For use on adult and pediatric patients. Laser Periodontal Procedures: Laser soft tissue curettage, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility). Tooth Whitening: Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth whitening.

Device Description

The Claros Dental Laser System is a portable laser that uses a gallium aluminum arsenide 810 nm diode laser module to provide optical energy via a contact fiber optic delivery system. Claros is used for multiple soft tissue. periodontal, and teeth whitening applications. The Claros Dental Laser System is comprised of the following main components: a light/ laser system console (including software, a display panel and controls); delivery devices: one or more handpieces; key cards for security; and protective eve wear.

AI/ML Overview

The provided text is a 510(k) summary for the Claros® Dental Laser System. It focuses on establishing substantial equivalence to a predicate device by comparing indications for use, principles of operation, and technical capabilities.

Crucially, the document does not contain information about acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), or any studies that would prove the device meets such criteria.

The "Performance Data" section only lists compliance with various electrical and laser safety standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, 21 CFR 1040.10 and 1040.11, and the European Medical Device Directive 93/42/EEC). These are general safety and performance standards for laser devices, not clinical efficacy or diagnostic performance metrics.

Therefore, I cannot provide the requested information from the given text.

To answer your specific questions, based solely on the provided text:

A table of acceptance criteria and the reported device performance: Not available.
Sample size used for the test set and the data provenance: Not available.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available.
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: Not available. This device is a surgical laser, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. This device described is a physical laser system, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available.
The sample size for the training set: Not available.
How the ground truth for the training set was established: Not available.

Summary

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Section 5: 510(k) Summary

The assigned 510(k) number is:

Company:

Elexxion AG Medizinische System Schützenstrasse 84 78315 Radolfzell, Germany Telephone: 49 7732 82299-0 Fax: 49-7732 82299-77

MAR 0 7 2007

KO63152

Contact: Johannes Mueller

Date Prepared: October 1, 2006

Claros® Dental Laser System Proprietary Names:

Classification Name: Surgical Powered Laser Instrument

Common Name: Dental Diode Laser

Classification Code: · Claros - Class II, 21 CFR 878.4810, GEX

Predicate Devices: Biolase LaserSmile, #K030539

Device Description: The Claros Dental Laser System is a portable laser that uses a gallium aluminum arsenide 810 nm diode laser module to provide optical energy via a contact fiber optic delivery system. Claros is used for multiple soft tissue. periodontal, and teeth whitening applications.

The Claros Dental Laser System is comprised of the following main components:

· a light/ laser system console (including software, a display panel and controls);

· delivery devices:
one or more handpieces;
· key cards for security; and

Please refer to Attachment 1

· protective eve wear.
Intended Use:

Performance Data:

The Claros Dental Laser System complies with the following standards:

IEC 60601-1:1998+A1:1991+A2:1995
IEC 60601-2-22:1995
IEC 60825-1:1993+A2:2001
21 CFR 1040.10 and 1040.11
· The European Medical Device Directive 93/42/EEC

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Substantial Equivalence:

Conclusion:

The Claros Dental Laser System (and accessories) shares the same or similar indications for use, principles of operation, overall technical and functional capabilities, and therefore is substantially equivalent for use in general and plastic surgery, and dentistry for surgical applications to the predicate device identified.

The Claros Dental Laser System (and accessories) is substantially equivalent to previously cleared dental devices and raises no new safety or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elexxion AG Medizinische System % Mr. Johannes Mueller Application Correspondent for Elexxion AG Grosse Lache 5 61273 Wehrheim Germany

MAR 0 7 2007

Re: K063152 Trade/Device Name: Claros® Dental Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 23, 2007 Received: February 26, 2007

Dear Mr. Mueller:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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Page 2 - Mr. Johannes Mueller

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOG 3152

510(k) Number (if known):

Device Name: Claros® Dental Laser System

Indications for Use:

Dental Soft Tissue Indications Including Pulpal Tissues*

Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectorny, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia, Operculectormy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening,

Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, and Vestibuloplasty.

*For use on adult and pediatric patients

Laser Periodontal Procedures

Laser soft tissue curettage, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

Tooth Whitening

Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth whitening

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

ce of CDRA, Office of Devito

Page 1 of 1

Division Sig J. Division of Ceneral, Restorative, and Neurological Devic

10(k) Number k06315^2

4-2

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.