Dental Soft Tissue Indications for: 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 Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakja 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 ulccrs of the oral mucosa. Vestibuloplasty. Laser Periodontal procedures, including: 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, 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.). Tooth Whitening Indications: Laser assisted whitening/bleaching of teeth. Light activation for bleaching materials for teeth whitening.

Device Description

The LaserSmile™ dental diode laser system may be used to perform several dental applications. LaserSmile™ uses advanced laser technology to incise, excise and ablate intraoral soft tissues and to activate a bleaching material for whitening/bleaching teeth safely and effectively. A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues and tooth bleaching compounds. A flexible fiberoptic handpiece delivers the LaserSmile™ laser energy. A visible light emitted from the handpicce distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.

AI/ML Overview

The provided text explicitly states that the LaserSmile™ device's substantial equivalence was demonstrated through "Equivalent performance specification", "Equivalent intended use", and a "Feature comparison table". However, it does not include any specific acceptance criteria or details of a study that proves the device meets such criteria in terms of quantitative performance metrics.

Instead, the submission relies on the concept of substantial equivalence to previously cleared devices (BioLase Technology, Inc. Waterlase® and Twilite™). This means that the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device, and therefore does not require new, extensive clinical performance studies to prove its efficacy.

Based on the provided document, here's what can be extracted:

A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria with quantitative performance metrics for the LaserSmile™ device. The basis for acceptance is stated as "Equivalent performance specification" to predicate devices, but no specifics are given.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set or clinical study data is provided for the LaserSmile™ device itself. The claim of equivalence is based on the device's technical specifications and intended use being similar to already cleared devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No test set requiring expert ground truth establishment is described for the LaserSmile™ device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication process is described.
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 study was done. The device described is a dental laser, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device (dental laser), not an algorithm. Performance is demonstrated through equivalence to other devices.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No new clinical study data with ground truth is presented for the LaserSmile™ device to establish its performance. The "ground truth" for its acceptance is implicitly the established safety and efficacy of the predicate devices it claims substantial equivalence to.
The sample size for the training set:
Not applicable. This is a hardware medical device, not a machine learning algorithm.
How the ground truth for the training set was established:
Not applicable. This is a hardware medical device, not a machine learning algorithm.

Summary of Acceptance Basis:

The LaserSmile™ device was approved based on substantial equivalence to previously cleared dental laser devices (BioLase Technology, Inc. Waterlase® and Twilite™). The rationale for acceptance rests on:

Equivalent performance specification: The technical specifications and operational parameters of LaserSmile™ are considered comparable to those of the predicate devices.
Equivalent intended use: The specific dental soft tissue and tooth whitening indications for LaserSmile™ are identical to indications already cleared for the predicate devices.
Feature comparison table: Although not provided in the excerpt, a comparison table would have been submitted to FDA to highlight the similarities between LaserSmile™ and the predicate devices.

The document implicitly states that no new clinical performance studies were deemed necessary because the device does not present unique applications, indications, materials, or specifications that differ significantly from its predicates.

Summary

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OCT 1 0 2003

030539

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510(k) Summary of Safety and Effectiveness Information

RegulatoryAuthority:	Safe Medical Devices Act of 1990,21 CFR 807.92
Company:	BioLase Technology, Inc.981 Calle AmanecerSan Clemente, CA 92673
Contact:	Ms. Ioana M. RizoiuBioLase Technology, Inc.981 Calle AmanecerSan Clemente, CA 92673(949) 361-1200 (949) 361-0204 Fax
Trade Name:	LaserSmileTM
Common Name:	Dental diode laser
Classification Name:	Surgical laser instrument
Classification Code:	79 GEX
Equivalent Devices:
	BioLase Technology, Inc. Waterlase®
	BioLase Technology, Inc. TwiliteTM

Device Description:

A flexible fiberoptic handpiece delivers the LaserSmile™ laser energy. A visible light emitted from the handpicce distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.

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630539 2/3

Indications for Use:

Dental Soft Tissue Indications for:

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 Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakja 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 ulccrs of the oral mucosa. Vestibuloplasty

Laser Periodontal procedures, including:

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, 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.)

Tooth Whitening Indications:

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

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030539 7/3

Contraindications:

All clinical procedures performed with LaserSmile™ 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 or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.

Patients with periodontal disease and/or exposed root surfaces are not candidates for laser tooth bleaching/whitening. Also, patients with damaged or fissured enamel are not candidates for laser bleaching/whitening.

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 K991994 (Twilite™, original indications for use), and in K011041 (Waterlase®, expanded indications for use).

Conclusion:

LaserSmile™ is substantially equivalent to dental products previously cleared for marketing. LaserSmile™ 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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

OCT 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ioana M. Rizoiu Vice President, Clinical Research and Development BioLase Technology, Inc. 981 Calle Amanecer San Clemente, CA 92673

Re: K030539

Trade/Device Name: LaserSmile™ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: July 11, 2003 Received: July 16, 2003

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 (OS) 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 - Mr. Daryl Wisdahl

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

feCelia M. Witten, Ph.D., M.D. 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): K030539

LaserSmile™ Device Name:

Indications for Use:

Dental Soft Tissue Indications for:

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 Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coaqulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of qinqival 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 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)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K630539

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Tooth whitening procedures, including:

Light activation for bleaching materials for teeth whitening. Laser-assisted whitening/bleaching of teeth.

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter-Use
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	Miriam C. Provost
	(Division Sign-Off)
	Division of General, Restorative and Neurological Devices

510(k) Number	K030539
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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.