WATERLASE MD

K083927 · Biolase Technology, Inc. · GEX · Oct 1, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083927
• Device Name: WATERLASE MD
• Applicant: Biolase Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).

Device Story

Waterlase MD is an Er,Cr:YSGG dental laser system for soft and hard tissue procedures; performs incision, excision, vaporization, ablation, and coagulation. Device utilizes flexible fiber optic delivery through a handpiece; features visible aiming light and three fiber optic illumination ports. Clinician adjusts power output, pulse duration, repetition rate, and air/water flow rates; spot size/geometry varied via interchangeable tips. Used in dental clinics by practitioners for periodontal pocket treatment, including removal of diseased/inflamed tissue and epithelium lining. Output provides precise laser energy for tissue management; aids in achieving new attachment to root surfaces. Clinical judgment required regarding patient medical history; caution advised for conditions like heart/lung disease, bleeding disorders, or immune deficiencies.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence is based on comparison to previously cleared dental laser devices.

Technological Characteristics

Er,Cr:YSGG laser system; flexible fiber optic delivery; adjustable power, pulse duration, repetition rate, and air/water flow; interchangeable tips for varying spot size/geometry; visible aiming light; fiber optic illumination ports.

Indications for Use

Indicated for patients requiring Er,Cr:YSGG laser-assisted new attachment procedures, specifically for cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.

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

• Millenium Dental Technologies, Inc
• Fotona d.d.
• Cynosure, Inc. Periolase Fidelis III Laser System Family Smart CO2

Submission Summary (Full Text)

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CONFIDENTIAL

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K083927

510k Summary of Safety and Effectiveness Waterlase® MD Expanded Indications for Use Biolase Technology, Inc. December 30, 2008

10/2

OCT - 1 2009

### 510(k) Summary of Safety and Effectiveness Information

Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

Company: Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618

Contact:

Ms. Ioana M. Rizoiu Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618 Tel: [phone] Fax: [phone]

Waterlase® MD

Trade Name:

Common Name: Er,Cr:YSGG laser

Classification Name: Surgical laser instrument

Classification Code: 79 GEX, a Class II device

Equivalent Devices:

Millenium Dental Technologies, Inc Fotona d.d. Cynosure, Inc.

Periolase Fidelis III Laser System Family Smart CO2

#### Device Description:

The Waterlase MD is a dental laser device previously cleared by the FDA (K031140) for hard and soft tissue dental indications, including periodontal procedures such as: 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, 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, full thickness flap, partial thickness flap, and split thickness flap.

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CONFIDENTIAL

K083927

510k Summary of Safety and Effectiveness Waterlase® MD Expanded Indications for Use Biolase Technology, Inc December 30, 2008

The Waterlase MD is capable of soft tissue incision, excision, vaporization, ablation and coagulation. In the periodontal pocket, the Waterlase MD is an effective laser for removing diseased/inflamed tissue, and the diseased epithelium lining from underlying connective tissues.

A flexible fiber optic terminated into the handpiece delivers the Waterlase MD laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In both hard and soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.

#### Indications for Use:

Waterlase MD Er, Cr. YSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)

#### Contraindications:

All clinical procedures performed with Waterlase MD 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 patient's physician is advisable when doubt exists regarding treatment.

#### Conclusion:

The indication included herein is the same as the indication that has been previously cleared by the FDA for other dental laser devices. Substantial equivalency for the Waterlase MD has been determined through comparison to previously cleared dental laser devices.

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Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring. MD 20993-0002

# Ms. Ioana Rizoiu Vice President of Clinical Research and Development Biolase Technology, Incorporated 4 Cromwell Irvine, California 92618

- Re: K083927
Trade/Device Name: Waterlase® MD Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use In General and Plastic Surgery and In Dermatology

OCT - 1 2009

Regulatory Class: II Product Code: GEX Dated: September 25, 2009 Received: September 28, 2009

#### 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 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.

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#### Page 2- Ms. Rizoiu

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

ht foc

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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K083927

## Indications for Use Statement

510(k) Number: K_____________________________________________________________________________________________________________________________________________________________

Device (Trade) Name: Waterlase®MD

# Indications for Use:

Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).

Prescription Use X (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)

Rin Harly for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083927