CUTERA GENESISPLUS LASER SYSTEM

K103626 · Cutera, Inc. · PDZ · Apr 5, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103626
• Device Name: CUTERA GENESISPLUS LASER SYSTEM
• Applicant: Cutera, Inc.
• Product Code: PDZ · General, Plastic Surgery
• Decision Date: Apr 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic.laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary.thoracic surgery, podiatry and urology for surgical and aesthetic applications.

Device Story

Cutera GenesisPlus Laser System is a console-based Nd:YAG laser (1064nm) for surgical and aesthetic procedures. Device delivers laser energy via handpiece with fiber optic system and optical lens; user activates emission via footswitch. System features LCD color touchscreen for control. Used by clinicians in dermatology and podiatry settings. Laser energy targets tissue for coagulation, hemostasis, ablation, or vaporization. Clinical benefit includes treatment of vascular/pigmented lesions, scars, wrinkles, and temporary increase of clear nail in onychomycosis patients. Device operates via facility power.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

1064nm Nd:YAG laser; flashlamp-pumped solid-state rod; pulsed output mode; 20-3500 mJ energy per pulse; 100-3000μs pulse duration; 5-100 Hz repetition rate; 630-680nm aiming beam; LCD color touchscreen interface; console-based form factor.

Indications for Use

Indicated for coagulation/hemostasis of benign vascular lesions (rosacea, poikiloderma of civatte), benign cutaneous lesions (warts, scars, striae), benign pigmented lesions, and treatment of wrinkles (periocular/perioral) in all skin types (Fitzpatrick I-VI). In podiatry, indicated for soft tissue ablation, vaporization, incision, excision, and coagulation (matrixectomy, warts, radical nail excision, neuromas) and temporary increase of clear nail in patients with onychomycosis (dermatophytes, yeast).

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

• PinPointe Footlaser (K09354, K083545)
• Cutera Nd:YAG Laser (K022226)

Submission Summary (Full Text)

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#### Attachment 5 510{K) Summary Cutera GenesisPlus Laser System

K103626

APR - 5 2011

This 510(K) Summary of safety and effectiveness for the Cutera GenesisPlus Laser is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Cutera, Inc. |
|------------|--------------|
|------------|--------------|

Address:

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:

3240 Bayshore Blvd.

Connie Hoy

Brisbane, CA 94005

415-657-5592 - phone

Instrument, Surgical, Powered, laser

PinPointe Footlaser K09354 and K093545

79-GEX, 21 CFR 878-48

Cutera Nd:YAG Laser K0222226

415-715-3592 - fax

[e-mail]

Contact Person:

Telephone: Fax: Email:

Preparation Date: November 24, 2010

Device Trade Name: Cutera GenesisPlus Laser System

Common Name: Nd:YAG Laser

Classification Name:

Legally Marketed Predicate Device:

Description of the Cutera GenesisPlus Laser:

The Cutera GenesisPlus Laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of a handpiece using a fiber optic delivery system with an optical lens at the aperture. . The user activates laser emission by means of a footswitch.

The Cutera GenesisPlus Laser is designed to provide laser energy for use in a variety of dermatology and podiatry procedures.

Intended use of the Cutera GenesisPlus Laser System: The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic.laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary.thoracic surgery, podiatry and urology for surgical and aesthetic applications.

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### Attachment 5 510(K) Summary Cutera GenesisPlus Laser System

## Specific Indications:

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### Dermatology:

The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloid scars), and warts.

The Cutera GenesisPlus laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The GenesisPlus laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

## Podiatry:

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

- . Matrixectomy
- . Periungual and subungual warts
- Plantar warts .
- Radical nail excision .
- . Neuromas

The Cutera GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).

Performance Data: None

Results of Clinical Study: None

Summary of Technological Characteristics:

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### Attachment 5 510(K) Summary Cutera GenesisPlus Laser System

| Features | Cutera Genesis Plus Laser | PinPointe Footlaser<br>K09354, K083545 | Cutera Nd:YAG Laser<br>K022226 |
|------------------|----------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------|
| Wavelength | 1064nm Nd:YAG | 1064nm Nd:YAG | 1064nm Nd:YAG |
| Aiming Beam | 630-680nm<br>(≤ 2.5mW) | 630-680nm<br>(≤ 2.5mW) | none |
| Energy per Pulse | 20-3500 mJ | 20 - 3500 mJ | ≤ 3500mJ |
| Fluence | 25.5 J/cm2 (with 1mm<br>spot) | 25.5 J/cm2 (with<br>1mm spot) | Up to 25,000J/cm2 (with<br>0.1mm spot) |
| Max Power | ≤ 100W | ≤100W | ≤100W |
| Pulse Duration | 100 - 3000μs | 100 - 3000 μs | ≤ 300ms |
| Spot Size | 1 mm (for Podiatry)<br>Up to 13mm (other<br>indications) | 1mm (for podiatry)<br>Other spot sizes<br>are not published | 0.1 - 13mm |
| Output mode | Pulsed | Pulsed, multimode | Pulsed |
| Repetition Rate | 5 - 100 Hz | 5 - 100 Hz | Single shot and up to 10<br>Hz |
| Laser Media | Flashlamp pumped<br>solid state rod | Flashlamp pumped<br>solid state laser rod | Flashlamp pumped solid<br>state rod |
| User Interface | LCD color<br>touchscreen | LCD color touch<br>screen or push-<br>button control<br>panel | Push button control or<br>LCD color touchscreen |

Conclusion:

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.. .. .. ..

The Culera GenesisPlus Laser is substantially equivalent to the Cutera Nd:YAG Laser (K022226) and to the PinPointe Footlaser (K09354 and K083545). The Cutera GenesisPlus Laser is substantially equivalent in terms of indication for use and technology based on technical characteristics.

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May 13, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Cutera, Inc. % Ms. Connie Hoy 3240 Bayshore Boulevard Brisbane, California 94005

Re: K103626

Trade/Device Name: Cutera GenesisPlus Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: PDZ, GEX Dated: March 24, 2011 Received: March 25, 2011

Dear Ms. Hoy:

This letter corrects our substantially equivalent letter of April 5, 2011.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

Image /page/3/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.

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Page 2 - Ms. Connie Hoy

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours, FOR

Peter D. Rumm Brokers Comment Hackback of the Production of the Production
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Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K 103626 510(k) Number (if known):

# Device Name : Cutera GenesisPlus Laser System

# Indications for Use:

The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic.laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary.thoracic surgery, podiatry and urology for surgical and aesthetic applications.

### Dermatology:

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The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte,, and treatment of benign cutaneous lesions, such as warts, scars and straie. The laser is also intended for the treatment of benign pigmented lesions.

The Cutera GenesisPlus laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The GenesisPlus laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin,

### Podiatry:

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

- Matrixectomy .
- . Periungual and subungual warts
- Plantar warts .
- Radical nail excision .
- Neuromas .

The Cutera GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) on of m

Division Sigh Division of Surgical. Orthopedic, and Restorative Devices

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510(k) Number K103626