NATURALASE CO2 LASER SYSTEM

K110333 · Focus Medical, LLC · ONG · Apr 12, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K110333
• Device Name: NATURALASE CO2 LASER SYSTEM
• Applicant: Focus Medical, LLC
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Apr 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue.

Device Story

NaturaLase CO2 is an RF-excited CO2 laser system used for dermatological procedures. It delivers laser energy via an articulated arm and a scanner that distributes energy in a controlled, uniform manner. The scanner enables fractional ablative resurfacing by creating micro spots of tissue ablation (120-micron spot size; up to 45 mJ energy per spot). Operated by clinicians in a medical setting, the device allows for precise tissue removal, resurfacing, or coagulation. The output is controlled by the scanner patterns, which the physician uses to treat specific skin areas. This process facilitates tissue healing and resurfacing, providing a therapeutic benefit for dermatological conditions requiring soft tissue management.

Clinical Evidence

Bench testing and histology data were provided. Histology study on human skin verified healing rates and micro spot characteristics at various energy settings. Punch biopsies measured spot size, treatment depth, and healing process over three weeks. Results showed excellent correlation with literature and control laser performance.

Technological Characteristics

RF-excited CO2 laser; articulated arm delivery; scanner-based fractional distribution; 120-micron micro spot size; up to 45 mJ energy per spot; Class II device.

Indications for Use

Indicated for dermatological procedures requiring ablation, resurfacing, or coagulation of soft tissue in patients requiring such interventions.

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

• Lutronic Mosaic eCO2 Laser System (K080496)

Submission Summary (Full Text)

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0333 . Pg 1 of

Focus Medical NaturaLase CO2 510(k) Submission

### 510(K) SUMMARY 5.

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APR 1 2 2012

| Applicant: | Focus Medical<br>23 Francis J. Clarke Circle<br>Bethel, CT 06801<br>203-730-8885 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Focus Medical<br>23 Francis J. Clarke Circle<br>Bethel, CT 06801 |
| Contact Person: | Mr. John B. Lee, Jr.<br>President<br>Focus Medical |
| Name of the Device: | NaturaLase CO2 Laser<br>Regulation Number: 21 CFR 878.4810<br>Regulation Name: Laser surgical instrument for use in general and plastic<br>surgery and in dermatology<br>Regulatory Class: Class II<br>Product Code: ONG |
| Predicate Device: | Lutronic Mosaic eCO2 Laser System (K080496) |
| Device Description: | The NaturaLase CO2 is an RF excited CO2 laser. The laser energy is<br>delivered through an articulated arm and with a scanner that distributes<br>the laser energy on the skin in a controlled way with uniform distribution.<br>The scanner design allows the system to ablate small micro spots of<br>tissue. The system has the ability to deliver micro spots with a size of 120<br>microns and up to 45 mJ of optical energy per micro spot. |
| Indications for Use: | The NaturaLase CO2 Laser System is indicated for use in<br>dermatological procedures requiring ablation (removal), resurfacing<br>or coagulation of soft tissue. |
| Substantial Equivalence: | The NaturaLase CO2 has the same intended use as the predicate device-<br>Lutronic Mosaic eCO2 Laser System (K080496). It uses the same<br>fundamental technology as the predicate device. Both systems use<br>similar RF excited CO2 laser tubes with the energy delivered through an<br>articulated arm and a scanner. Both use a 120 micron micro spot and<br>have various scanner patterns that deliver ablative fractional resurfacing. |
| Histology Data: | Histology data was collected to demonstrate the performance of the laser.<br>The study included laser treatment of human skin to verify the healing rate<br>and the characteristics of the micro spot at various energy settings.<br>Punch biopsies were used to measure spot size, treatment depth and the<br>healing process over a three week period. The wounds and the healing<br>process showed an excellent correlation with literature and with the<br>control laser. |
| Conclusion: | The specifications, indications for use and performance of the NaturaLase<br>CO2 Laser is substantially equivalent to the legally marketed predicate<br>device. Histology data confirmed the treatment parameters and the safety<br>and effectiveness of the laser. It raises no new issues of safety and<br>effectiveness and should be approved for marketing under the general<br>controls provisions of the Federal Food, Drug, and Cosmetic Act. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

#### Public Health Service

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

APR 1 2 2012

Focus Medical % Mr. John B. Lee, Jr. President 23 Francis J. Clarke Circle Bethel. Connecticut 06801

Re: K110333

Trade/Device Name: NaturaLase CO2 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: II Product Code: ONG Dated: March 20, 2012 Received: April 3, 2012

Dear Mr. Lee:

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 piemarket 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. 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

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### Page 2 - Mr. John B. Lee, Jr.

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/CDRH0ffices/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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

iely yours,

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

Enclosure

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Focus Medical NaturaLase CO2 510(k) Submission

110333 pg1. of 1

#### INDICATIONS FOR USE STATEMENT 4.

### Intended Use Statement

The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue.

> Prescription Use (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) The

Neil R. Doyle for nxm

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110333

Confidential