WATERLASE MD DERM

K071734 · Biolase Technology, Inc. · GEX · Jan 25, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K071734
• Device Name: WATERLASE MD DERM
• Applicant: Biolase Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing. Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.

Device Story

Waterlase® MD Derm is an Er,Cr:YSGG laser system for soft tissue surgery. Device delivers laser energy via fiber optic cable to handpiece; energy applied to incise, excise, ablate, or coagulate tissue. Water spray provides hydration and cooling. Visible aiming light pinpoints treatment area; three fiber optic ports provide illumination. Clinician adjusts power output, pulse duration, repetition rate, and air/water flow rates based on procedure. Interchangeable tips vary spot size and geometry. Used by physicians in clinical settings for dermatologic and general surgical applications. Output allows precise tissue management; benefits include controlled ablation and coagulation with reduced thermal damage compared to traditional methods.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Er,Cr:YSGG laser system; fiber optic delivery; adjustable pulse duration, repetition rate, and air/water flow. Features visible aiming light and illumination ports. Interchangeable tips for spot size/geometry control. Class II device.

Indications for Use

Indicated for dermatologic and general surgical soft tissue procedures including incision, excision, ablation, vaporization, and coagulation. Applicable to epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, tumor/cyst debulking, biopsy, and skin resurfacing. Contraindicated for patients with specific medical conditions such as anesthesia allergies, heart disease, bleeding disorders, sleep apnea, or immune deficiencies; requires clinical judgment.

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™
• DermaLase™
• MCL 30 Dermablate

Submission Summary (Full Text)

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# K071734

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

| Regulatory Authority: | Safe Medical Devices Act of 1990,<br>21 CFR 807.92 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Company: | BioLase Technology, Inc.<br>4 Cromwell<br>Irvine, CA 92618 |
| Contact: | Ms. Ioana M. Rizoiu<br>BioLase Technology, Inc.<br>4 Cromwell<br>Irvine, CA 92618<br>Tel: [phone]<br>Fax: [phone] |
| Trade Name: | Waterlase® MD Derm |
| Common Name: | Er,Cr:YSGG laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX, MXF, DZI a Class II device |
| Equivalent Devices: | Millenium™<br>DermaLase™<br>MCL 30 Dermablate<br><br>Biolase Technology, Inc.<br>Endo Technic Corp.<br>Asclepion Laser Technologies |

#### Device Description:

The Waterlase®MD Derm medical laser system is a device used to perform a variety of soft tissue indications. 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. For soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues and the field of view clean.

fiber optic terminated into the handpiece delivers flexible ব the Waterlase®MD Derm 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 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.

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#### Indications for Use:

Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing.

Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision. tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.

### Cautions, Precautions and Contraindications;

All clinical procedures performed with Waterlase® MD Derm 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, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.

#### Substantial Equivalence:

The indications included herein are the same as indications that have been previously cleared by the FDA for other devices. Substantial equivalency for the Waterlase®MD Derm has been determined through comparison to previously cleared devices.

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Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

JAN 2 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolase Technology, Inc. % Ms. Ioana Rizoiu VP. Clinical Research and Development 4 Cromwell Irvine, California 92618

Re: K071734

Trade/Device Name: Waterlase® MD Derm 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: October 29, 2007 Received: October 30, 2007

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 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 Assistances e 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. Mikkelsen

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

Enclosure

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### Indications for Use

### 510(k) Number: K071734

### Device (Trade) Name: Waterlase® MD Derm

Indications for Use:

- Use of the device is indicated for the incision, excision, ablation, vaporization and . coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of turnors, cysts, diagnostic biopsy and skin resurfacing.
- Use of the device is further indicated for the incision, excision, vaporization and . coagulation of soft tissue during general surgical applications where skin incision, tissue disection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.

Prescription Use X (Part 21 CFR 801 Subpart D)

### AND/OR

Over-the-Counter Use_ (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milheron

(Division Sign-Off) (Division Biggeral, Restorative, and Neurological Devices

K071734

**510(k) Number**