General Indications: Class I, II, III, IV and V cavity preparation; Caries removal; Hard tissue surface roughening or etching; Enameloplasty, excavation of pits and fissures for placement of sealants. Root Canal Hard Tissue Indications: Tooth preparation to obtain access to root canal; Root canal preparation including enlargement; Root canal debridement and cleaning. Root Canal Disinfection: Laser root canal disinfection after endodontic treatment. Endodontic Surgery (Root Amputation) Indications: Flap preparation - incision of soft tissue to prepare a flap and expose the bone; Cutting bone to prepare a window access to the apex (apices) of the root(s); Apicoectomy - amputation of the root end; Root end preparation for retrofill amalgam or composite; Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex. Bone Surgical Indications: Cutting, shaving, contouring and resection of oral osseous tissues (bone); Osteotomy. 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; 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; Gingivoplasty; 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 (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; Vestibuloplasty. Laser Periodontal Procedures: Full thickness flap; Partial thickness flap; Split thickness flap; 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 junctional epithelium; Removal of granulation tissue from bony defects; Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve 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 lengthening.

Device Description

The Waterlase MD is a dental laser device previously cleared by the FDA for hard and soft tissue dental indications (K031140, K071363). The only changes from the previously cleared device are the addition of the Turbo handpiece, which combines minor software and graphics changes that will be added to the Waterlase MD laser system. This software does not change the operational software, but adds a "Select" icon on the control panel, and unassigned pre-sets fields for use by the dentist to store preferred setting selections. There are no other hardware or software changes to the Waterlase MD device pending herein when compared to the device cleared under K031140 and K071363. Materials used for the Turbo handpiece are the same as those for the MD Gold handpiece. Biocompatibility testing of these materials was conducted in compliance with 21 CFR Part 820, Quality System Regulation, Subpart C, Sec. 820.30 - Design Controls, and ISO 13485-2003, Section 7.3 - Design and Development; documented results (on file) confirmed there is no biocompatibility risk presented by these materials.

AI/ML Overview

This document describes a Special 510(k) submission for the KOGOLFI Waterlase® MD with a new Turbo Handpiece accessory submitted by Biolase Technology, Inc. The core of this submission is to demonstrate substantial equivalence to previously cleared devices (K031140, K071363) by showing that the new accessory does not introduce new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain specific acceptance criteria for performance metrics in the traditional sense of a study with quantitative results. Instead, the "acceptance criteria" for this Special 510(k) is the demonstration of substantial equivalence to predicate devices. This means that:

Acceptance Criteria (Implicit for Special 510(k))	Reported Device Performance
No change in Indications for Use: The new accessory (Turbo Handpiece) should not alter the intended clinical applications as previously cleared for the Waterlase MD.	Met: "The indications included herein are the same as the indications that have been previously cleared by the FDA for the Waterlase®MD (K031140, K071363)." The provided "Indications for Use" section lists the exact same indications as the predicate devices.
No change in Contraindications: The new accessory should not introduce any new contraindications.	Met: "All Contraindications remain the same as for the previously cleared device, Waterlase®MD (K031140)." The document explicitly states this.
No change in fundamental technology or mode of operation that would raise new questions of safety or effectiveness: The changes should be minor and not impact the core safety and performance characteristics of the laser system.	Met: "The only changes from the previously cleared device are the addition of the Turbo handpiece, which combines minor software and graphics changes that will be added to the Waterlase MD laser system. This software does not change the operational software, but adds a 'Select' icon on the control panel, and unassigned pre-sets fields for use by the dentist to store preferred setting selections. There are no other hardware or software changes to the Waterlase MD device pending herein when compared to the device cleared under K031140 and K071363." This demonstrates the changes are superficial.
Biocompatibility of new materials (if any) meets established standards: Any new materials introduced by the accessory must be biocompatible.	Met: "Materials used for the Turbo handpiece are the same as those for the MD Gold handpiece. Biocompatibility testing of these materials was conducted in compliance with 21 CFR Part 820, Quality System Regulation, Subpart C, Sec. 820.30 - Design Controls, and ISO 13485-2003, Section 7.3 - Design and Development; documented results (on file) confirmed there is no biocompatibility risk presented by these materials." This confirms biocompatibility was addressed and meets regulatory requirements.
Overall substantial equivalence demonstrated: The new device (Waterlase MD with Turbo Handpiece) is as safe and effective as the predicate devices and does not introduce new questions of safety or effectiveness. This is the overarching "acceptance criterion" of a 510(k) submission, especially a Special 510(k).	Met: "Substantial equivalency for the Waterlase MD with the Turbo Handpiece has been determined through comparison to the previously cleared Waterlase MD." This is the explicit conclusion of the submission, and the FDA's clearance letter affirms this determination.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No separate "test set" or clinical study data (in terms of patient samples) is referenced for this Special 510(k). This type of submission relies on the existing safety and effectiveness data of the predicate devices. The changes applied (Turbo Handpiece, minor software/graphics) are considered "minor" enough not to necessitate new clinical testing on human subjects for performance.

3. 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. As no clinical test set was used for performance evaluation, there were no experts establishing ground truth in this context. The "ground truth" for this submission are the established safety and effectiveness profiles of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set was used.

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 dental laser system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

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

Not applicable. This device is a physical laser system requiring human operation, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices (Waterlase® MD, K031140, K071363), which were cleared by the FDA based on their own submissions likely involving a combination of performance testing, bench testing, biocompatibility testing, electrical safety testing, and potentially clinical data or reliance on existing scientific literature for similar devices. For this Special 510(k), the "ground truth" is that the modifications do not alter these established profiles.

8. The sample size for the training set:

Not applicable. There is no AI model or "training set" mentioned or implied by the nature of this submission. The "software" changes are described as minor graphical and preset additions, not a learning algorithm.

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

Not applicable, as no training set was used.

Summary

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KOGOLFI

Special 510k Summary of Safety and Effectiveness Waterlase® MD New Accessor Biolase Technology, Inc January 23, 2009

FER = 1 2009

Special 510(k) Summary of Safety and Effectiveness Information

Regulatory Authority:

CONFIDENTIAL :

Company:

Contact:

Safe Medical Devices Act of 1990, 21 CFR 807.92

Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618

Ms. Ioana M. Rizoiu Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618 Tel: (949) 226-8144 Fax: (949) 273-6680

Trade Name:

Waterlase® MD

Common Name:

Er, Cr: YSGG laser

Classification Name:

Classification Code:

Surgical laser instrument 79 GEX, a Class II device

Equivalent Devices:

Waterlase® MD Biolase Technology, Inc. K031140, July 7, 2004

Device Description:

Materials used for the Turbo handpiece are the same as those for the MD Gold handpiece. Biocompatibility testing of these materials was conducted in compliance with 21 CFR Part 820, Quality System Regulation, Subpart C, Sec. 820.30 - Design Controls, and ISO 13485-2003, Section 7.3 - Design and Development; documented results (on file) confirmed there is no biocompatibility risk presented by these materials.

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Indications for Use:

General Indications *

I Class I, II, III, IV and V cavity preparation
I Caries removal
Hard tissue surface roughening or etching
트 Enameloplasty, excavation of pits and fissures for placement of sealants
- - For use on adult and pediatric patients

Root Canal Hard Tissue Indications

Tooth preparation to obtain access to root canal ■
트 Root canal preparation including enlargement
지 Root canal debridement and cleaning

Root Canal Disinfection

트 Laser root canal disinfection after endodontic treatment

Endodontic Surgery (Root Amputation) Indications

트 Flap preparation = incision of soft tissue to prepare a flap and expose the bone.
트 Cutting bone to prepare a window access to the apex (apices) of the root(s).
1 Apicoectomy - amputation of the root end.
요 Root end preparation for retrofill amalgam or composite.
. Removal of pathelogical tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex

NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

Bone Surgical Indications

트 Cutting, shaving, contouring and resection of oral osseous tissues (bone)
비 Osteotomy

Soft Tissue Indications including Pulpal Tissues*

Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

보 Excisional and incisional biopsies
. Exposure of unerupted teeth
l Fibroma removal
트 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 트
Gingival troughing for crown impressions 피
B Gingivectomy
Gingivoplasty 트

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CONFIDENTIAL

Gingival incision and excision
Hemostasis
트 implant recovery
I Incision and drainage of abscesses
Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during 트 apical surgery
파 Leukoplakia
. Operculectomy
I Oral papillectomies
Operculectomy
1 Oral papillectomies
에 Pulpotomy
Pulp extirpation
8 Pulpotomy as an adjunct to root canal therapy
D Root canal debridement and cleaning
Reduction of gingival hypertrophy ■
Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues
- (i.e., granulation tissue) from around the apex

NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) nust be submitted to a qualified laboratory for histopathological evaluation.

Soft tissue crown lengthening
Treatment of cariker sores, herpetic and aphthous ulcers of the oral mucosa ■
Vestibuloplasty
- For use on adult and pediatric patient

Laser Periodontal Procedures

Full thickness flap
제 Partial thickness flap
Split thickness flap
트 Laser soft tissue curettage
. Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
제 Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining
- junctional epithelium
Removal of granulation tissue from bony defects
트 Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleedingindex, probe depth, attachment loss and tooth mobility)
제 Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
요 Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
트 Osseous crown lengthening

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All Contraindications remain the same as for the previously cleared device, Waterlase®MD (K031140)

Contraindications:

All clinical procedures performed with the Waterlase®MD 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, which might contraindicate a local procedure. Such conditions may include, but are not limited to,

allergy to local or topical anesthetics, heart disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from the patient's physician is advisable when doubt exists regarding treatment.

Conclusion:

The indications included herein are the same as the indications that have been previously cleared by the FDA for the Waterlase®MD (K031140, K071363). Substantial equivalency for the Waterlase MD with the Turbo Handpiece has been determined through comparison to the previously cleared Waterlase MD.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2009

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

Re: K090181

Trade/Device Name: Waterlase MD (Turbo Handpiece) 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: January 23, 2009 Received: January 26, 2009

Dear Mr. Christensen:

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. Ilisting 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

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Page 2 - Ms. Ioana Rizoiu

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.

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 N. Mulhausen

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

510(k) Number (if known):

Device Name: Waterlase MD (Turbo Handpiece)

Indications for Use:

General Indications *

Class I, II, III, IV and V cavity preparation .
Caries removal 에
Hard tissue surface roughening or etching
Enameloplasty, excavation of pits and fissures for placement of sealants

For use on adult and pediatric patients

Root Canal Hard Tissue Indications

B Tooth preparation to obtain access to root canal
Root canal preparation including enlargement
Root canal debridement and cleaning M

Root Canal Disinfection

Laser root canal disinfection after endodontic treatment 에

Endodontic Surgery (Root Amputation) Indications

트 Flap preparation = incision of soft tissue to prepare a flap and expose the bone.
지 Cutting bone to prepare a window access to the apex (apices) of the root(s).
Apicoectomy amputation of the root end.
Root end preparation for retrofill amalgam or composite.
Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex

NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

Bone Surgical Indications

Cutting, shaving, contouring and resection of oral osseous tissues (bor
Osteotomy

Soft Tissue Indications including Pulpal Tissues*

Incision, excision, vaporization, ablation and coagulation of oral soft assussion

Excisional and incisional biopsies
Exposure of unerupted teeth

Division of General, Restorative, and Neurological Devices

510(k) Number_

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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 피 impactions)
Frenectomy and frenotomy
Gingival troughing for crown impressions 트
트 Gingivectomy
이 Gingivoplasty
해 Gingival incision and excision
트 Hemostasis
지 implant recovery
트 Incision and drainage of abscesses
Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during ■ apical surgery
을 Leukoplakia
l Operculectomy
Oral papillectomies
Operculectomy
Oral papillectomies
Pulpotomy
Pulp extirpation
Pulpotomy as an adjunct to root canal therapy
Root canal debridement and cleaning
Reduction of gingival hypertrophy

NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

I Soft tissue crown lengthening
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa ■
I Vestibuloplastv

For use on adult and pediatric patient .

Laser Periodontal Procedures

Full thickness flap
Partial thickness flap I
Split thickness flap
Laser soft tissue curettage

l mucosa

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K090181

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 I junctional epithelium

junct to root canal
ement and cleaning

Removal of pathelegical tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues

(i.e., granulation tissue) from around the apex

(i.e., granulation tissue) from around the apex
TE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted

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Removal of granulation tissue from bony defects
Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Osteoplasty and esseous 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 lengthening

Prescription Use X Use (Part 21 CFR 801 Subpart D) Over-the-Counter

(21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

1
	œ

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

K090181 510(k) Number

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.