NaturaLase CO2 Laser System

K152529 · Focus Medical, LLC · GEX · Feb 4, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152529
• Device Name: NaturaLase CO2 Laser System
• Applicant: Focus Medical, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 4, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NaturaLase CO2 laser operating in tractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.

Device Story

RF-excited CO2 laser system; delivers 10.6 μm laser energy via articulated arm to surgical or scanning handpieces. Input: user-defined parameters via touchscreen controller. Transformation: switching-mode power supply converts line voltage to high voltage for laser tube; optical bench aligns beam; scanner/handpiece distributes energy to target tissue. Output: controlled tissue ablation, incision, or coagulation. Used in clinical settings (dermatology, plastic surgery, ENT, etc.) by trained physicians. Benefits: precise, uniform tissue interaction via selective photothermolysis; enables both traditional surgical procedures and fractional skin resurfacing.

Clinical Evidence

Bench testing only. Performance testing demonstrated device functions according to specifications. Conformance to IEC 60601-1 (safety), IEC 62366, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1 (laser safety) confirmed. Biocompatibility consistent with ISO 10993. Software verification and validation testing completed.

Technological Characteristics

RF-excited CO2 laser; 10.6 μm wavelength; 30W max power. 7-joint spring-balanced articulated arm; 3mW @ 650nm aiming beam. Microprocessor-based touchscreen interface. Electrical: 110VAC/60Hz or 220VAC/50Hz. Conforms to IEC 60601-1, IEC 62366, IEC 60825-1. Biocompatibility per ISO 10993.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissues (including intraoral) in aesthetic, ENT, gynecology, neurosurgery, dental/oral, and genitourinary surgery; also indicated for ablative skin resurfacing in fractional mode.

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

• NaturaLase CO2 Laser System (K110333)
• YOULASER CO2 Laser System (K123573)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

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

February 4, 2016

Focus Medical, LLC % Michail Pankratov Principal MMP Medical Associates LLC 16 Appleton Street Waltham, Massachusetts 02453

Re: K152529

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: Class II Product Code: GEX. ONG Dated: January 7, 2016 Received: January 8, 2016

Dear Michail Pankratov:

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. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

Device Name NaturaLase CO2 Laser System

Indications for Use (Describe)

NaturaLase CO2 laser operating in tractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| <div> <span> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(K) SUMMARY

# As required by section 21 CFR 807.92

# I. General Information

| Applicant: | Focus Medical, LLC |
|-------------------|---------------------------------|
| | 2 Francis J Clarke Circle |
| | Bethel, CT 06801 |
| | TEL: [phone] |
| | FAX: [phone] |
| Contact Person: | Michail M. Pankratov, MD, PhD |
| | MMP Regulatory Consultants, LLC |
| | 16 Appleton Street |
| | Waltham, MA 02453 |
| | TEL: [phone] |
| | [e-mail] |
| Preparation Date: | August 26, 2015 |

# II. Device Information

| Trade Name: | NaturaLase CO2 Laser System |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | CO2 Laser System |
| Classification: | Class II |
| Regulation Number: | 878.4810 |
| Product Code: | GEX; ONG |
| Classification Name: | Powered Laser Surgical Instrument |
| Review Panel: | General & Plastic Surgery |
| Predicate Devices: | K110333 - NaturaLase CO2 Laser System, Focus<br>Medical<br>LLC; K123573 – YOULASER CO2 Laser System, Quanta<br>System S.P.A. |

{4}------------------------------------------------

## III. Device Description:

The NaturaLase CO2 is an RF excited CO2 laser. The main console of the NaturaLase CO2 laser system contains the following components:

- CO2 laser tube
- Power Supply
- Optical bench assembly
- Articulated Arm
- Hand-pieces: scanning and surgical
- Touch screen controller/user interface

The laser source is a sealed CO2 laser tube that is mounted vertically within the main cabinet and the laser beam is passed from the laser tube into the articulated arm. The NaturaLase CO2 laser unit is equipped with a switching-mode power supply, which converts the input line voltage to the high voltage required for laser operation. The optical bench assembly consists of the articulated arm mount, the aiming beam diode laser (3mW @ 650nm) and optics to align the laser beam and the aiming beam to the articulated arm. The laser energy is delivered through an articulated arm to a hand-piece (scanner or surgical) that distributes the laser energy on the target in a controlled and uniformed way. The user-interface microprocessor-based touch screen allows operator to control all operating functions.

# IV. Indication for Use:

NaturaLase CO2 laser operating in traditional non-fractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, urology, neurosurgery, dental and oral surgery and genitourinary surgery. NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.

#### V. Technological Characteristics:

The NaturaLase CO2 laser technical specifications are very similar to the predicate devices. All have the same intended use, technological characteristics and operating principles as the previously cleared NaturaLase CO2 Laser system (K110333) and Quanta System YOULASER Laser System (K123573). The NaturaLase CO2 laser design and components are very similar to those of the predicate devices. Their treatment handpieces connected to the articulated arm that is connected to the main console where the user interface is located. Differences between the NaturaLase CO2 laser and predicate devices in specific maximum energy levels and fluence delivered do not raise any new safety or effectiveness issues because the NaturaLase CO2 laser parameters fall within the range of parameters delivered by the predicate devices.

#### VI. Testing Performance

All performance testing demonstrated that the NaturaLase CO2 laser performs according to specifications and functions as intended. The NaturaLase CO2 laser system was determined to be in conformance with all applicable standards. Electrical safety and electromagnetic compatibility (EMC) testing for the NaturaLase CO2 laser system was conducted by an independent laboratory

{5}------------------------------------------------

in accordance with IEC 60601-1. Medical electrical equipment, part 1: general requirements for basic safety and essential performance. The NaturaLase CO2 laser was determined to be in conformance with applicable IEC standards (IEC 62366, 60601-1-6, 60601-1-6, 60601-2-22, and IEC 60825-1). The biocompatibility of the NaruraLase CO2 laser is consistent with the ISO 10993.

Software verification and validation testing results are acceptable for software release.

### VII. Summary of Substantial Equivalence

Review of the technological characteristics for the primary predicate device and the NaturaLase CO2 Laser shows close similarity in parameters principally for generating tissue effects (see Table below).

The NaturaLase CO2 laser has the same intended use as the predicate devices with similar indications for use. It presents similar technological characteristics as the predicate devices including the laser type, wavelengths, device design, pulse width, frequency, spot sizes and system components. Few differences between the NaturaLase CO2 laser and its predicate devices in terms of maximum pulse energy, fluence, pulse duration, etc, do not present any new concerns of safety and effectiveness. The NaturaLase CO2 laser and its predicates all operate with the same mechanism of action based on selective photothermolysis. Therefore, the NaturaLase CO2 laser has the same intended use and similar indications for use, technological characteristics, and principles of operation as predicate devices. The NaturaLase CO2 laser is substantially equivalent to the predicate devices.

{6}------------------------------------------------

| 510(k) | | K123573 | K110333 | |
|----------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | | Quanta System S.P.A | Focus Medical LLC | Focus Medical LLC |
| Device Name | | YOULASER CO2 Laser | NaturaLase CO2 | NaturaLase CO2 |
| Device<br>Classification<br>Name | | Powered Laser Surgical<br>Instrument | Powered Laser Surgical<br>Instrument<br>Microbeam/Fractional Output | Powered Laser Surgical<br>Instrument<br>Microbeam/Fractional Output |
| Regulation Number | | 878.4810 | 878.4810 | 878.4810 |
| Product Code | | GEX | ONG | GEX, ONG |
| Laser Source | | CO2 | CO2 | CO2 |
| Wavelength | | 10.6 μm | 10.6 μm | 10.6 μm |
| Power | | Up to 30 W | Up to 30 W | Up to 30 W |
| Pulse<br>width | Fraction | 0.2 - 20 ms | 0.2-10 ms | 0.2-10 ms |
| | Surgical | 0.5 – 80 ms | - | .2 to 10ms |
| Spot Size | Fraction | 300 μm | 120 and 300 μm | 120 and 300 μm |
| | Surgical | 200, 400, 1000 μm | | 300 μm |
| Energy Emission | | Pulse/single pulse/cw | Pulse/single pulse/cw | Pulse/single pulse/cw |
| Energy to tissue | | | 10-45 mJ per micro spot | 10-45 mJ per micro spot |
| Peak power | | | 60 W | 60 W |
| Aiming beam | | <4 mW @ 650 nm | 3 mW @ 650 nm | 3 mW @ 650 nm |
| Articulated arm | | 7-mirrors | 7-joint spring-balanced | 7-joint spring-balanced |
| Electric Power | | 230 VAC?50-60 Hz | 110VAC/60 Hz or 220 VAC/50 Hz | 110VAC/60 Hz or 220 VAC/50 Hz |
| Dimensions | | 48x55x120 cm | 34x46x126 cm | 34x46x126 cm |
| Weight | | 30 Kg | 35 Kg | 35 Kg |
| Indications for use | | YOULASER CO2 laser when used in traditional non-fractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical | The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue, additionally, the | NATURALASE CO2 laser operating in traditional non-fractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical |

# TABLE - Comparison of the NaturaLase CO2 with the Predicate Devices

{7}------------------------------------------------

| specialties including aesthetic<br>(dermatology and plastic surgery),<br>otolaryngology<br>(ENT),<br>gynecology,<br>neurosurgery, dental and oral<br>surgery and genitourinary surgery.<br><b>YOULASER CO2</b> laser when<br>used in fractional mode (dot<br>scanner) is indicated for ablative<br>skin resurfacing | fractional spot sizes are used in the<br>treatment of wrinkles; rhytides,<br>furrows, fine lines, textural<br>irregularities, pigmented lesions<br>and vasculardyschromia. | specialties including aesthetic<br>(dermatology and plastic surgery),<br>otolaryngology<br>(ENT),<br>urology,<br>neurosurgery, dental and oral surgery<br>and genitourinary surgery.<br><b>NATURALASE CO2</b> laser<br>operating in fractional mode is<br>indicated for ablative skin<br>resurfacing. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description<br>The YOULASER CO2 Laser<br>System includes a single model<br>named YOULASER CO2 emitting<br>a maximum power of<br>30 Watt at 10.6 µm. The<br>YOULASER CO2 Laser<br>composed externally of metallic<br>shell with a frontal polyurethane<br>panel containing the touch screen<br>display. On this panel the key<br>switch, emergency red push button<br>and the operation led are inserted<br>too. On the rear panel the<br>footswitch connector, the remote<br>interlock, the power switch are<br>located. The system is composed<br>of power supply, CO2 laser source<br>with air cooling system, optical<br>bench, articulated arm with CO2<br>scanner, the control electronics.<br>The electronic, based on a<br>microcontroller, manages the<br>voltage power supply and the CO2<br>laser source. | The NaturaLase CO2 is an RF<br>excited CO2 laser. The laser energy<br>is delivered through an articulated<br>arm and with a scanner, that<br>distributes the laser energy on the<br>skin in a controlled way with<br>uniform distribution. The scanner<br>design allows the system to ablate<br>small micro spots of tissue. The<br>system has the ability to deliver<br>micro spots with a size of 120<br>microns and up to 45 mJ of optical<br>energy per micro spot.<br>The NaturaLase CO2 laser system<br>consists of<br>-CO2 laser tube,<br>-Power supply,<br>-Closed loop cooling system,<br>- user interface control<br>- an articulated arm<br>- a scanning hand piece<br>- a traditional hand piece | The NaturaLase CO2 is an RF<br>excited CO2 laser. The laser energy<br>is delivered through an articulated<br>arm and with a scanner, that<br>distributes the laser energy on the<br>skin in a controlled way with<br>uniform distribution. The scanner<br>design allows the system to ablate<br>small micro spots of tissue. The<br>system has the ability to deliver<br>micro spots with a size of 120<br>microns and up to 45 mJ of optical<br>energy per micro spot.<br>The NaturaLase CO2 laser system<br>consists of<br>-CO2 laser tube,<br>-Power supply,<br>-Closed loop cooling system,<br>- user interface control<br>- an articulated arm<br>- a scanning hand piece<br>- a traditional hand piece |