CUTERA ER:YSGG LASER HANDPIECE

K063867 · Cutera, Inc. · GEX · Mar 27, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063867
• Device Name: CUTERA ER:YSGG LASER HANDPIECE
• Applicant: Cutera, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cutera Er: YSGG Laser Handpiece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue. Dermatology and Plastic Surgery Indications include: treatment of wrinkles and skin resurfacing. Opthalmology Indications include: Incision, excision, vaporization and coagulation of tissue surrounding the eye and orbit.

Device Story

Cutera Er:YSGG Laser Handpiece is an optional accessory for Xeo and Solera Opus laser systems; emits 2790nm laser energy for soft tissue surgery. Device features water-cooled laser within handpiece; utilizes computer-controlled scanner for energy delivery. Operated by clinicians in dermatology, plastic surgery, or ophthalmology settings. Output consists of laser energy for tissue ablation/coagulation; enables precise surgical procedures on skin or periocular tissue. Benefits include controlled tissue removal and coagulation during surgical interventions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Laser wavelength: 2790nm; Er:YSGG medium. Water-cooled handpiece. Computer-controlled scanner. Accessory to Xeo and Solera Opus systems. Class II device.

Indications for Use

Indicated for soft tissue excision, incision, ablation, vaporization, and coagulation in dermatology, plastic surgery (wrinkles, skin resurfacing), and ophthalmology (tissue surrounding eye and orbit).

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

• Sciton Profile Er:YAG (K060033)
• BioLase Oculase MD (K062354)
• MLT Erbium:YAG (K032599)
• BioLase Waterlase (K031140)

Submission Summary (Full Text)

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K063867

## Attachment 5 510(k) Summary for the Cutera Er:YSGG Laser System

### I. General Information

MAR 2 7 2007

| Submitter: | Cutera, Inc.<br>3240 Bayshore Blvd<br>Burlingame, CA 94010 |
|-----------------|------------------------------------------------------------|
| Contact Person: | Connie Hoy |

Telephone: [phone] Fax:

Summary Preparation Date: December 30, 2006

#### II. Names

| Device Proprietary Name: | Cutera Er:YSGG Laser Handpiece |
|--------------------------|---------------------------------------------------------|
| Classification Name: | Instrument, Powered, Laser, GEX<br>Opthalmic Laser, HQF |
| Common Name: | Dermatology Laser<br>Opthalmic Laser |

### III. Predicate Devices

| K060033 | Sciton Profile Er:YAG |
|---------|-----------------------|
| K062354 | BioLase Oculase MD |
| K032599 | MLT Erbium:YAG |
| K031140 | BioLase Waterlase |

### IV. Product Description/Technological Characteristics

The Cutera Er:YSGG Laser handpiece is an optional handpiece for the currently marketed Xeo and Solera Opus laser systems. The handpiece emits laser energy at a wavelength of 2790nm. The water cooled laser is located in the handpiece and utilizes a computer controlled scanner.

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Premarket Notification 510(k) Submission: Cutera Er: YSGG Laser Handpiece

### V. Statement of Intended Use

The Cutera Er: YSGG Laser System is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue. For Dermatology and Plastic Surgery, indications include: treatment of wrinkles and skin For Opthalmology, indications include: Incision, excision, vaporization resurfacing. and coagulation of tissue surrounding the eye and orbit.

### VI. Rationale for Substantial Equivalence

The Cutera Er:YSGG Handpiece shares the same general indications for use as the currently marketed predicate devices, and does not raise any issues with safety and effectiveness. There are no unique applications, indication, materials or specification presented in this application. The Cutera Er:YSGG Handpiece is therefore substantially equivalent to the currently marketed predicate devices.

### VII. Safety and Effectiveness Information

Technologically, the Cutera Er:YSGG Handpiece is substantially equivalent to the listed predicate devices. Therefore the risks and benefits for the Cutera Er:YSGG Handpiece are comparable to the predicate devices.

Cutera therefore believes that there are no new questions of safety or effectiveness raised by the introduction of this device.

## VIII. Conclusion

The Cutera Er: YSGG Handpiece was found to be substantially equivalent to currently marketed devices. The Cutera Er:YSGG shares similar indications for use, design features, and similar functional features as the currently marketed predicate 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 stylized eagle or bird-like figure with outstretched wings, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the left side of the bird figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cutera, Inc. % Ms. Connie Hoy VP of RA/QA 3240 Bayshore Boulevard Brisbane, California 94005

MAR 2 7 2007

Re: K063867

Trade/Device Name: Cutera ER:YSGG Laser Handpiece 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: February 21, 2007 Received: February 22, 2007

Dear Ms. Hoy:

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 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.

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# Page 2 – Ms. Connie Hoy

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 Office of Compliance at [phone]. 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 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 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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## Attachment 4 Indications For Use Statement

510(k) Number (if Known):

### Device Name: Cutera Er: YSGG Laser Handpiece

Indications for Use:

The Cutera Er: YSGG Laser Handpiece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue.

## Dermatology and Plastic Surgery

Indications include: treatment of wrinkles and skin resurfacing.

### Opthalmology

Indications include: Incision, excision, vaporization and coagulation of tissue surrounding the eye and orbit.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <img alt="check mark" src=""/> |
|------------------|--------------------------------|
|------------------|--------------------------------|

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

| 510(k) Number | |
|---------------|----------------------|
| | Over-The-Counter Use |