Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy 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. Vestibuloplasty Laser Periodontal procedures, including: Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

Device Description

The EZLase™ dental diode laser system may be used to perform various soft tissue dental applications. The system uses advanced laser technology to incise, excise, vaporize, coagulate and ablate intra-oral soft tissues. A Gallium Aluminum Arsenide (GaAlAs) and/or an Indium Gallium Arsenide Phosphorous solid-state laser diode emit infrared laser energy to the various oral soft tissues targeted during procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.

AI/ML Overview

This document is a 510(k) summary for the EZLase™ dental diode laser, which seeks substantial equivalence to already cleared devices. It does not contain a study demonstrating the device meets specific acceptance criteria in the way a clinical trial for a new therapeutic or diagnostic device would.

Instead, the submission for the EZLase™ dental diode laser relies on demonstrating substantial equivalence to predicate devices. This means that the device is shown to be as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval). The "acceptance criteria" here are met by proving this substantial equivalence, rather than by achieving specific performance metrics against a defined ground truth in a new clinical study.

Therefore, many of the requested sections (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, and how training set ground truth was established) are not applicable to this type of regulatory submission in the way they would be for a novel diagnostic AI algorithm.

Here's a breakdown based on the provided text, focusing on how substantial equivalence is demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (as stated in the document)
Equivalent Intended Use: The device performs the same indications for use as predicate devices.	The EZLase™ has the same Indications for Use as predicate devices (LaserSmile™, LVI Lase, DioDent II) for various soft tissue dental applications and laser periodontal procedures. These indications include incision, excision, vaporization, ablation, coagulation of oral soft tissues, and specific procedures like frenectomy, gingivectomy, and sulcular debridement.
Equivalent Performance Specifications: The device's technical specifications are comparable to predicate devices.	The document states "Equivalent performance specification" but does not detail specific metrics or a comparative table. It implies that the underlying technology and output parameters are similar enough to achieve the same clinical effects.
Equivalent Technology/Mechanism of Action: The device achieves its intended use through the same mechanism as predicate devices.	The EZLase™ uses a Gallium Aluminum Arsenide (GaAlAs) and/or Indium Gallium Arsenide Phosphorous (InGaAsP) solid-state laser diode to emit infrared laser energy transmitted via a flexible fiberoptic cable. This mechanism is implicitly considered equivalent to the predicate diode lasers.
No Unique Applications, Indications, Materials or Specifications: The device does not introduce new features that raise different questions of safety or effectiveness.	The document states, "There are no unique applications, indications, materials or specifications presented herein."
Feature Comparison: A comparison validates the equivalence of features.	A "Feature comparison table" is mentioned as evidence of equivalence, but the actual table is not provided in the excerpt.

2. Sample size used for the test set and the data provenance

Not Applicable in this context. This 510(k) submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, not on a new clinical study with a test set of patient data to prove effectiveness. The "data provenance" would refer to the existing regulatory clearances for the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No new ground truth needed to be established for this submission as it relies on substantial equivalence.

4. Adjudication method for the test set

Not Applicable. No new test set requiring adjudication was performed.

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

Not Applicable. This device is a surgical laser, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant to its regulatory submission.

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

Not Applicable. This is a hardware device (surgical laser), not an algorithm.

7. The type of ground truth used

"Ground truth" here is embodied by the established safety and effectiveness of the predicate devices cleared by the FDA. The premise of a 510(k) is that if a new device is substantially equivalent to an already cleared device, then it is also safe and effective. The FDA's initial clearance of the predicate devices would have relied on various forms of evidence, potentially including clinical data, performance testing, and literature review, but not necessarily for this new device's submission.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As per point 8.

Summary

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RegulatoryAuthority:	Safe Medical Devices Act of 1990,21 CFR 807.92	K061898
Company:	BioLase Technology, Inc.4 CromwellIrvine, CA 92618		JAN 26	2007
Contact:	Ms. Ioana M. RizoiuBioLase Technology, Inc.4 CromwellIrvine, CA 92618Tel: (949) 226 8144 Fax: (949) 273 6680
Trade Name:	EZLase TM
Common Name:	Dental diode laser
Classification Name:	Surgical laser instrument
Classification Code:	79 GEX
Equivalent Devices:		LaserSmileTM
BioLase Technology, Inc.
Hoya ConBio, Inc.		LVI lase
Hoya ConBio, Inc.		DioDent II

510(k) Summary of Safety and Effectiveness Information

Device Description:

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K061898

Indications for Use:

Dental Soft Tissue Indications for:

Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy 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. Vestibuloplasty

Laser Periodontal procedures, including:

Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket

Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

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15061898

Contraindications:

6.6.1 All clinical procedures performed with EZLase™ must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea, an immune system deficiency and other such conditions. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.

Substantial Equivalence:

There are no unique applications, indications, materials or specifications presented herein. All the submitted indications for use retain the same meaning as their equivalent indications cleared by the FDA in the following 510k clearances: K030539 for LaserSmile™, K041721 for LVI Lase and K050274 for DioDent II.

Conclusion:

EZLase™ is substantially equivalent to dental products previously cleared for marketing. EZLase™ performs the same indications for use through the same mechanism as the other cleared devices. Evidence of equivalence has been demonstrated through the following:

. Equivalent performance specification
. Equivalent intended use
Feature comparison table

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolase Technology Inc. % Ms. Ioana M. Rizoiu VP. Clinical Research and Development 4 Cromwell Irvine, California 92618

JAN 2 6 2007

Re: K061898 Trade/Device Name: EZLase™ 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: December 19, 2006 Received: December 20, 2006

Dear Ms. Rizoiu:

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 – Ms. Ioana M. Rizoiu

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.

Hyatt Rhoden

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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510(k) Number (if known): K061898

EZLase™M Device Name:

Indications for Use:

Dental Soft Tissue Indications for:

Laser Periodontal procedures, including:

Laser soft tissue curettage Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket

Stupt Rhodes for MXM
Division Sign-Off

Division of General, Restorative and Neurological Devices

(k) Number K 06 1898

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Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

Stephen Rhodes for mxm
(Mission Sign-Off)

Wision of General, Restorative nd Neurological Devices

Number KOC 1898

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.