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, Operculectomy, Oral papillectornies, 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. 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 nano Dental Laser System is a variant of the Claros Dental Laser System. It 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 nano is used for multiple soft tissue, periodontal, and teeth whitening applications. The Claros nano 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; and protective eye wear.

AI/ML Overview

The provided text covers a 510(k) summary for the Claros nano Dental Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria for the device itself in terms of clinical effectiveness metrics.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, training set size and ground truth) are not available in the provided text.

Here's a summary of what can be extracted or inferred from the text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as performance metrics tied to specific values. Instead, the primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to existing legally marketed devices.
Reported Device Performance: The device is stated to comply with several international and US standards related to medical electrical equipment safety, laser safety, and radiation control.

Acceptance Criteria (Implied for 510(k))	Reported Device Performance (Compliance)
Substantial Equivalence to Predicate Devices	- Shares same/similar indications for use
	- Shares same/similar principles of operation
	- Shares same/similar overall technical and functional capabilities
	- Does not raise new safety or effectiveness issues
Compliance with relevant standards	- IEC 60601-1:1988+A1:1991+A2:1995
	- IEC 60601-2-22:1995
	- IEC 60825-1:1993+A1:1997+A2:2001
	- 21 CFR 1040.10 and 1040.11

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

Not Applicable / Not Provided. The submission is focused on technical specifications and substantial equivalence, not a clinical trial with a defined test set for performance.

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

Not Applicable / Not Provided. There is no mention of a test set with ground truth established by experts.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided.

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. This is a hardware device (laser system), not an AI-powered diagnostic or assistance tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided. As noted above, this is a laser and not an algorithm.

7. The Type of Ground Truth Used

Not Applicable / Not Provided. There is no mention of ground truth in the context of device performance in the provided text.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. This is a hardware device submission, not a machine learning algorithm.

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

Not Applicable / Not Provided. This is a hardware device submission, not a machine learning algorithm.

Summary

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Section 5: 510(k) Summary

The assigned 510(k) number is:

081652

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

AUG 2 8 2008

Dr. Holger Ernst Contact:
June 9th, 2008 Date Prepared:
Claros nano Dental Laser System Proprietary Names:

Surgical Powered Laser Instrument Classification Name:

Dental Diode Laser Common Name:

· Claros nano Class II, 21 CFR 878.4810, GEX Classification Code:
Biolase LaserSmile, #K030539 Predicate Devices: Elexxion Claros,#K063152

The Claros nano Dental Laser System is a variant of the Device Description: Claros Dental Laser System. It 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 nano is used for multiple soft tissue, periodontal, and teeth whitening applications.

The Claros nano 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; and

Please refer to Attachment 1

· protective eye wear.
Intended Use:

Performance Data:

The Claros nano Dental Laser System complies with the following standards:
- · IEC 60601-1:1988+A1:1991+A2:1995
- IEC 60601-2-22:1995
- · IEC 60825-1:1993+A1:1997+A2:2001
- · 21 CFR 1040.10 and 1040.11

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Substantial Equivalence:	The Claros nano 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.
Conclusion:	The Claros nano 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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2008

Elexxion AG % Dr. Holger Ernst Head of R&D Technology Schützenstrasse 84 78315 Radolfzell, Germany

Re: K081652

Trade/Device Name: Claros nano 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: June 9, 2008 Received: June 12, 2008

Dear Dr. Ernst:

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.

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Page 2 - Dr. Holger Ernst

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark M. Milliman

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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Indications for Use

081652

510(k) Number (if known):

Device Name: Claros nano 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, Operculectomy, Oral papillectornies, 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

Alask N. Miliken
Sip Off

and Neurologi

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 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.