WATERLASE

• K Number: K030523
• Device Name: WATERLASE
• Manufacturer: BIOLASE TECHNOLOGY, INC.
• Date Cleared: 2004-01-30 ( 345 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K011041 , K012511 , K013908 , K022803

Intended 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
• • 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.

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.