WATERLASE, VERSION 3.0

K081589 · Biolase Technology, Inc. · GEX · Jun 13, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081589
• Device Name: WATERLASE, VERSION 3.0
• Applicant: Biolase Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 13, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 - Incision and drainage of periapical abscesses. 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, infected, inflamed and necrosed soft issue 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, infected, 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 - Root canal debridement and cleaning - 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 - 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 * For use on adult and pediatric patient

Device Story

Waterlase 3.0 is an Er,Cr:YSGG dental laser system. It utilizes laser energy combined with water atomization spray to perform hard tissue procedures (cutting, etching, removing tissue) and soft tissue procedures (incising, excising, ablating, coagulating). A flexible fiberoptic handpiece delivers laser energy; a visible light beam pinpoints the treatment area. Clinicians adjust power output, pulse energy, repetition rate, and air/water flow rates. Used in dental clinics by practitioners to treat hard and soft oral tissues; benefits include precise tissue removal and hemostasis. Output is direct laser-tissue interaction; clinical decision-making relies on practitioner judgment and patient medical history.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use identical to the predicate device.

Technological Characteristics

Er,Cr:YSGG laser system; flexible fiberoptic handpiece; adjustable power, pulse energy, frequency, and air/water flow rates. Operates via laser-tissue interaction with water atomization for hard tissue cooling/ablation. Class II device.

Indications for Use

Indicated for adult and pediatric patients requiring oral hard and soft tissue procedures, including cavity preparation, caries removal, endodontic surgery, bone surgery, periodontal procedures, and soft tissue incision/excision/ablation.

Regulatory Classification

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.

Predicate Devices

• Waterlase (K030523)

Submission Summary (Full Text)

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# JUN 1 3 2008

Biolase Technology, Inc. Special 510(k) Summary Statement Waterlase®3.0 CONFIDENTIAL

CONFIDENTIAL
K081588

#### 510(k) SPECIAL Summary (As required by 21CFR807.92, 21CFR807.81(a)(3), FDA Memorandum #K97-1)

| Date Prepared: | June 3, 2008 |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Company: | Biolase Technology, Inc.<br>4 Cromwell<br>Irvine, CA 92618<br>Tel: [phone]<br>Fax: [phone] |
| Contact: | Ms. Ioana M. Rizoiu<br>VP, Clinical R&D<br>Tel: [phone]<br>email: [e-mail] |
| Trade Name: | Waterlase® 3.0 |
| Common Name: | Er,Cr:YSGG laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX, MXF, DZI a Class II device |
| Predicate Devices: | Waterlase®<br>Biolase Technology, Inc<br>K030523 (January 30, 2004) |

#### DEVICE DESCRIPTION:

The Waterlase® 3.0 hydrokinctic dental laser system is a diverse device utilized to perform a variety of applications. For hard tissue procedures the Waterlase 3.0 uses the Erbium, dental Chromium: Ytrium, Scandium, Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er. 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 tissues clean.

A flexible fiberoptic handpiece delivers the Waterlase@3.0 laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the

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power output, pulse energy, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. to specific user requirements.

#### INDICATIONS FOR USE:

#### 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
- · 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, infected, inflamed and necrosed soft issue within the periodontal pocket

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- · 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, infected, 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
- · Root canal debridement and cleaning
- · 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

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- · 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

* For use on adult and pediatric patient

### CONTRAINDICATIONS:

All clinical procedures performed with the Waterlase 3.0 must be subject 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, lung 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 indications that have been previously cleared by the FDA for the predicate device. Substantial equivalency for the Waterlase 3.0 has been determined through comparison to a previously cleared device.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is black and white and appears to be a scanned or reproduced image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 3 2008

Biolase Technology, Inc. % Ms. Ioana M. Rizoiu VP. Clinical R&D 4 Cromwell Irvine, California 92618

Re: K081589 Trade/Device Name: Waterlase® 3.0 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: June 3, 2008 Received: June 5, 2008

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

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Page 2 - Ms. Ioana M. 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K08 1589

Device Name: Waterlase® 3.0

# Indications for Use:

### General Indications *

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

* For use on adult and pediatric patients

### Root Canal Hard Tissue Indications

- 트 Tooth preparation to obtain access to root canal
- 트 Root canal preparation including enlargement
- Root canal debridement and cleaning I

### Endodontic Surgery (Root Amputation) Indications

- E Flap preparation - incision of soft tissue to prepare a flap and expose the bone,
- 8 Cutting bone to prepare a window access to the apex (apices) of the root(s).
- 트 Apicoectomy - amputation of the root end.
- Root end preparation for retrofill amalgam or composite. 트
- 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

- I 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 ■

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

510(k) Number_KV8

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- 페 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 세 impactions)
- 트 Frenectomy and frenotomy
- 제 Gingival troughing for crown impressions
- 트 Gingivectomy
- I Gingivoplasty
- Gingival incision and excision 트
- 트 Hemostasis
- 트 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
- 후 Leukoplakia
- 피 Operculectomy
- 프 Oral papillectomies
- 트 Operculectomy
- 트 Oral papillectomies
- l Pulpotomy
- Pulp extirpation
- " Pulpotomy as an adjunct to root canal therapy
- 프 Root canal debridement and cleaning
- Reduction of gingival hypertrophy ■
- 발 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.

- 보 Soft tissue crown lengthening
- 포 Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- .. Vestibuloplasty

* For use on adult and pediatric patient

### Laser Periodontal Procedures

- I Full thickness flap
- I Partial thickness flap
- I Split thickness flap

.

- . Laser soft tissue curettage
(Division Sign-Off)
Division of General, Restorative,

and Neurological Devices

Laser soft tissue curettage

**510(k) Number** K081589

Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal

- pocket 트 Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium

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- . Removal of granulation tissue from bony defects
- l 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)
- 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) AND/OR

Over-the-Counter

(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)

Nijel Osh for mkn
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K081589