K Number

Device Name

Manufacturer

BIOLASE TECHNOLOGY, INC.

Date Cleared

2004-07-07

(454 days)

Product Code

GEX,DZI,MXF

Regulation Number

878.4810

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

K052354,K063867,K083927,K090181,K101658

Intended Use

Hard Tissue
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

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
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.)
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 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
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Soft tissue crown lengthening
Treatment of canker sores, herpetic and aphthous ulcers 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 Gamet (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 energy. 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 510(k) premarket notification for the Waterlase® Er,Cr:YSGG laser and Hydrokinetic System provides information on its indications for use and states its substantial equivalence to previously cleared devices. However, it does not contain the specific details required to answer your request about acceptance criteria and a study demonstrating the device meets those criteria.

Here's why and what information is missing:

Acceptance Criteria and Device Performance: The document does not explicitly list any acceptance criteria (e.g., performance metrics, thresholds, or clinical endpoints) that a study would be designed to meet. Consequently, it also does not report the device's performance against such criteria.
Study Details: There is no mention of an actual study conducted to prove the device meets any specific criteria. The document relies on the concept of "substantial equivalence" to previously cleared devices. This means that instead of conducting new clinical trials or performance studies against defined criteria for this specific submission, the manufacturer asserts that the Waterlase® device is as safe and effective as other legally marketed predicate devices.

Therefore, for your specific questions, the answers are largely "not applicable" or "not provided in the given document."

Here's a breakdown of the requested information based on the provided text, highlighting the missing elements:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., specific clinical outcomes, precision, accuracy)	Reported Device Performance
Not specified in the document.	Not reported in the document.

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

Sample Size (Test Set): Not applicable, as no specific performance study or test set is described.
Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable, as no specific study data is presented.

3. Number of Experts and Their Qualifications for Ground Truth

Not applicable, as no study involving expert-established ground truth for a test set is described.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary.
Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this device is a laser system, not an AI-assisted diagnostic tool, and no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical laser system, not an algorithm, and no standalone performance study is described.

7. Type of Ground Truth Used

Not applicable, as no specific study utilizing ground truth is described. The approval is based on substantial equivalence.

8. Sample Size for the Training Set

Not applicable, as this is a medical device (laser system) and not an AI/machine learning algorithm requiring a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as this is a medical device (laser system) and not an AI/machine learning algorithm requiring a training set with established ground truth.

Summary of the Document's Approach:

The provided 510(k) summary (K031140) for the Waterlase® device demonstrates its "substantial equivalence" to existing, legally marketed devices. This regulatory pathway typically involves comparing the new device's technological characteristics and intended uses to a predicate device, rather than requiring new, full-scale clinical trials or explicit performance studies against specific acceptance criteria. The document lists the device description and an extensive range of indications for use, but it does not detail any studies designed to prove performance against quantitative metrics.

Summary

{0}------------------------------------------------

K031140 1/4

JUL - 7 2004

510(k) Summary of Safety and Effectiveness Information

Regulatory Authority:	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) 940-0066 (949) 361-0204 Fax
Trade Name:	Waterlase®
Common Name:	Er,Cr:YSGG laser and Hydrokinetic System
Classification Name:	Surgical laser instrument
Classification Code:	79 GEX, MXF, DZI

Equivalent Devices:

BioLase Technology, Inc.

Waterlase®

Device Description:

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

K031140 2/4

Indications for Use:

Hard Tissue

General Indications*

. Class I, II, III, IV and V cavity preparation
. Caries removal
t 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

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).
Apicoectorny 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 Iesions) 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

t 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

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

K031140 3/4

. 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 )
. Ostectorny (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 bionsies
. 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 .
4 Gingival troughing for crown impressions
Gingivectorny ●
. Gingiyoplastv
� 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 papillectomics
Pulpotomy ◆
◆ Pulp extirnation
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 liyperplastic . 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.

. Soft tissue crown lengthening

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

K031140 4/4

. Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
. Vestibuloplasty
- - For use on adult and pediatric patients

Cautions, Precautions 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 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.

Substantial Equivalence:

Waterlase is substantially equivalent, in terms of safety and efficacy, to previously cleared devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of three stylized human figures connected by flowing lines, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2004

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

Re: K031140 Trade/Device Name: Waterlase® 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, MXF, DZI Dated: April 19, 2004 Received: April 22, 2004

Dear Ms. Rizoiu:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the 112) 2011-12-12 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). and Oosmeter For (110) war the device, subject to the general controls provisions of the Act. The r ou may a controls provisions of the Act include requirements for annual registration, listing of general voltaren want facturing 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 11 your device to such additional controls. Existing major regulations affecting your device can may or subject to back as a success 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 r hat 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 - Ms. Ioana M. Rizoiu

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse of substantial equivalence of your device to a legally prematics notification. "The 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 If you desire specific as noliance 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 other general michinal 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,

Daniel Knare

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): _ K U 3 1/40

Device Name: Waterlase®

Indications for Use: Waterlase®

Use of Waterlase® may be indicated for:

Hard Tissue

General Indications*

해 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

Flap preparation incision of soft tissue to prepare a flap and expose the bone. 를
제 Cutting bone to prepare a window access to the apex (apices) of the root(s).
l Apicoectorny - amputation of the root end.
에 Root end preparation for retrofill amalgam or composite.
그 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

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

Laser Periodontal Procedures

이 Full thickness flap
l Partial thickness flap
l Split thickness flap

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

드 Laser soft tissue curettage
발 Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
트 Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
이 Removal of granulation tissue from bony defects
r 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)
피 Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
트 Ostectorny (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
피 Osseous crown lengthening

Soft Tissue Indications including Pulpal Tissues*

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

I Excisional and incisional biopsies
t Exposure of unerupted teeth
트 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 風 teeth (hard and soft tissue impactions)
는 Frenectomy and frenotomy
해 Gingival troughing for crown impressions
. Gingivectomy
대 Gingivoplastv
사 Gingival incision and excision
해 Hemostasis
이 Implant recovery
l Incision and drainage of abscesses
Laser soft tissue curettage of the post-extraction tooth sockets and the periapical 노 area during apical surgery
지 Leukoplakia
발 Operculectomy
l Oral papillectomies
l Pulpotomy
Pulp extirpation 체
대 Pulpotomy as an adjunct to root canal therapy
비 Root canal debridement and cleaning
트 Reduction of gingival hypertrophy

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

Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other leslons) must be submitted to a qualified laboratory for histopathological evaluation.
Soft tissue crown lengthening
피 Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
에 Vestibuloplasty
- - For use on adult and pediatric patients

Miriam C. Provost

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

510(k) Number K031146

Prescription Use ﮨﮯ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

=&&=========================================================================================================================================================================

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.