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). 후
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 8 tissues (i.e., granulation tissue) from around the apex
I Incision and drainage of periapical abscesses
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 (bone)
- Osteotomy

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 and 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.)
t Osseous crown lengthening

Soft Tissue Indications Including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, includina:

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 so area during apical surgery
Leukoplakia .
Operculectomy
. Oral papillectomies
. Pulpotomy
. Pulp extirpation
Pulpotomy as an adjunct to root canal therapy
Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic . tissues (i.e., granulation tissue) from around the apex
. Root canal debridement and cleaning
Reduction of gingival hypertrophy
Soft tissue crown lengthening .
Treatment of canker sores, herpetic and aphthous uicers of the oral mucosa •
. Vestibuloplasty
- For use on adult and pediatric patients

Device Description

The Waterlase hydrokinetic dental laser system is a diverse device utilized to perform a variety of dental applications. For hard tissue procedures the Waterlase uses the Erbium, Chromium: Yttrium, Scandium, Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er,Cr.YSGG laser energy is applied to incise, excise or ablate these tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping the tissues clean.

A flexible fiberoptic handpiece delivers the Waterlase laser e nergy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate and air and water flow rates are adjustable to specific user requirements.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness Information for the Waterlase® Er,Cr:YSGG laser, submitted by BioLase Technology, Inc. in 2004. This submission is for expanded indications for use for the Waterlase device, which had previous 510(k) clearances.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or provide performance data from a new study demonstrating the device meets these criteria. Instead, the submission relies on the concept of substantial equivalence to previously cleared devices and indications.

Acceptance Criteria (Explicitly Stated)	Device Performance (Based on Substantial Equivalence Claim)
No unique applications, indications, materials, or specifications presented.	The expanded indications for use retain the same meaning as equivalent indications cleared by the FDA in prior 510(k) clearances (K011041, K012511, K013908, K022803).
The device is substantially equivalent to legally marketed predicate devices.	Waterlase is substantially equivalent in relation to its previous clearances for the stated indications.

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

No new test set or clinical study data is presented in this 510(k) summary to support the expanded indications. The submission leverages existing clearances and the "substantial equivalence" argument. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of data for a new test set is not applicable here.

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

Not applicable. No new test set or ground truth establishment process is described in this 510(k) for the expanded indications. The basis is substantial equivalence to previously cleared devices and their established indications.

4. Adjudication Method for the Test Set:

Not applicable. No new test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC comparative effectiveness study was not performed as this submission relies on substantial equivalence for expanded indications, not a new performance study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a surgical laser instrument, not an AI algorithm. Its performance is directly tied to its physical interaction with tissues and its operation by a human clinician.

7. The Type of Ground Truth Used:

Not applicable for a new study in this submission. For the original clearances of the predicate devices, the "ground truth" would have been established through clinical validation demonstrating the safety and effectiveness of the dental procedures when performed with the laser, likely involving standard clinical assessments, pathology (for tissue removal indications), and outcome data for the specific procedures.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. (See #8)

Summary of the Study (or Basis for Clearance):

This 510(k) submission for the BioLase Waterlase® device is based on the claim of substantial equivalence, rather than a new clinical study with specific acceptance criteria and performance data. The core argument is that the expanded indications for use (as detailed in the document, covering various hard tissue, root canal, bone surgical, endodontic surgery, laser periodontal, and soft tissue procedures) are not unique and are already equivalent to indications previously cleared by the FDA for the Waterlase® system itself or closely related predicate devices (K011041, K012511, K013908, K022803).

The "study" in this context is the comparison of the proposed expanded indications against previously cleared indications to demonstrate sameness or equivalence. The conclusion explicitly states: "The indications included herein are the same as those included in previous clearances. Waterlase is therefore substantially equivalent in relation to the previous clearances."

Therefore, this document does not describe a new clinical trial or performance study with defined acceptance criteria and results. Instead, it argues that the expanded uses fall within the scope of already established safe and effective applications for similar devices, including earlier versions of the Waterlase system.

Summary

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030523 1/4

	510(k) Summary of Safetyand Effectiveness Information	JAN 30 2004
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:	Waterlase®
Common Name:	Er,Cr:YSGG laser
Classification Name:	Surgical laser instrument
Classification Code:	79 GEX, MXF, DZI
Equivalent Devices:
BioLase Technology, Inc.	Waterlase®

Device Description:

{1}------------------------------------------------

K030523

Indications for Use:

Hard Tissue

(General Indications*

Class I, II, III, IV and V cavity preparation
2/4
. Caries removal
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

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

Bone Surgical Indications

Cutting, shaving, contouring and resection of oral osseous tissucs (bone)
. Osteotomy

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

Laser Periodontal Procedures

Full thickness flap .
. Partial thickness flap
Split thickness flap .
Laser soft tissue curettage .
Laser removal of discased, infected, inflamed and necrosed soft tissue t the provinsity of the first of the first the first the first the first the first the first the first the first the finitial was and the finalisting the finalism of the fini within the periodontal pocket
Removal of highly inflamed edematous tissuc affected by bacteria . penetration of the pocket lining and junctional epithelium
Removal of granulation tissue from bony defects .
Sulcular debridement (removal of diseased, inflamcd 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)

{2}------------------------------------------------

030523 3/4

WaterLase™ Expanded Indications for Use BioLase Technology, Inc. October 29, 2003

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

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 the 이 unerupted teeth (hard and soft tissue impactions)
Frenectomy and frenotomy .
Gingival troughing for crown impressions *
Gingivectomy *
Gingivoplasty ◆
Gingival incision and excision ◆
Hemostasis& coagulation �
s Implant recovery
. Incision and drainage of abscesses
- Incision and drainage of periapical 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
◆ Reduction of gingival hypertrophy
Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and . hyperplastic tissues (i.e. granulation tissue). Note: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Root canal debridement and cleaning .
Soft tissue crown lengthening .
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa ◆
. Vestibuloplasty

For use on adult and pediatric patients

Cautions and Contraindications:

All clinical procedures performed with Waterlase must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always

{3}------------------------------------------------

030513 4/4

WaterLase™ Expanded Indications for Use BioLase Technology, Inc. October 29, 2003

be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercisc caution for gencral medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart discase, lung disease, bleeding disorders, sleep apnea or an immune system deficiency. 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 presented indications for use retain the same meaning as their equivalent indications cleared by the FDA in K011041 (Waterlase", expanded soft tissue indications including Sulcular Debridement), K012511 (Waterlase " indications for Root Canal), K013908 (Waterlase , indications for oral osseous procedures) and K022803 (Waterlase , indications for Endodontic Surgery).

Conclusion:

The indications included herein are the same as those included in previous clearances. Waterlase is therefore substantially equivalent in relation to the previous clearances.

{4}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three parallel lines that curve and converge.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2004

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

Re: K030523 Trade/Device Name: Waterlase® Regulation Number: 21 CFR 878.4810 Regulation Name: Lascr surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Codc: GEX Dated: October 31, 2003 Received: November 3, 2003

Dear Ms. Rizoiu:

We have reviewed your Scction 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 adultcration.

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 Codc 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.

{5}------------------------------------------------

Page 2 -

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.

Celia 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

{6}------------------------------------------------

510(k) Number (if known): K030523

Device Name: Waterlase®

Indications for Use:

Use of Waterlase may be indicated for:

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 .
- For use on adult and pediatric patients

Root Canal Hard Tissue Indications

Tooth preparation to obtain access to root canal .
Root canal preparation including enlargement •
Root canal debridement and cleaning

Endodontic Surgery (Root Amputation) Indications (soft and hard tissue)

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). 후
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 8 tissues (i.e., granulation tissue) from around the apex
I Incision and drainage of periapical abscesses
- 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 (bone)
- Osteotomy

Laser Periodontal Procedures

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

Mark A. Milken

Neurological Devices

K030523

{7}------------------------------------------------

- 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
. 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.)
t Osseous crown lengthening

Soft Tissue Indications Including Pulpal Tissues*

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

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 so area during apical surgery
Leukoplakia .
Operculectomy
. Oral papillectomies
. Pulpotomy
. Pulp extirpation
Pulpotomy as an adjunct to root canal therapy
Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic . tissues (i.e., granulation tissue) from around the apex
. Root canal debridement and cleaning
Reduction of gingival hypertrophy

"K030523

{8}------------------------------------------------

Soft tissue crown lengthening .
Treatment of canker sores, herpetic and aphthous uicers of the oral mucosa •
. Vestibuloplasty
- - For use on adult and pediatric patients

for Mark A. Mellers

K030523

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

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.

Reduction of gingival hypertrophy

Device Description:

Indications for Use:

Hard Tissue

(General Indications*

Root Canal Hard Tissue Indications

Bone Surgical Indications

Endodontic Surgery (Root Amputation) Indications

Laser Periodontal Procedures

Soft Tissue Indications Including Pulpal Tissues*

Cautions and Contraindications:

Substantial Equivalence:

Conclusion:

510(k) Number (if known): K030523

General Indications*

Root Canal Hard Tissue Indications

Endodontic Surgery (Root Amputation) Indications (soft and hard tissue)

Bone Surgical Indications

Laser Periodontal Procedures

Soft Tissue Indications Including Pulpal Tissues*

Reduction of gingival hypertrophy

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.