CORTEX CO2 / ER:YAG LASER SYSTEM

K110897 · Sandstone Medical Technologies, LLC · GEX · Jul 1, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110897
• Device Name: CORTEX CO2 / ER:YAG LASER SYSTEM
• Applicant: Sandstone Medical Technologies, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CO2 laser is indicated for coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology. The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

Device Story

Cortex CO2 / Er:YAG Laser System is a dual-modality surgical laser console. CO2 laser energy (10.6 micron) is delivered via a 7-joint articulated arm; Er:YAG laser energy (2940nm) is delivered via a specialized handpiece containing the laser cavity. System features a touch screen interface and footswitch activation. Used in clinical settings (dermatology, plastic surgery, etc.) by trained healthcare professionals. CO2 mode supports CW and Super pulse operation for soft tissue management. Er:YAG mode supports superficial skin ablation and wrinkle treatment. Closed-loop liquid cooling system manages thermal output. Device provides precise tissue interaction for surgical and aesthetic procedures, enabling controlled ablation and coagulation.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Sealed-off CO2 laser (10.6 micron) and Er:YAG laser (2940nm). CO2 power: 0.5-40W; Er:YAG power: 2.4W. Features 7-joint articulated arm for CO2 delivery. Closed-loop liquid cooling. Touch screen interface. Electrical input: 110VAC/60Hz or 220VAC/50Hz. Aiming beam: 650nm diode (3mW).

Indications for Use

Indicated for soft tissue coagulation, vaporization, ablation, or cutting in dermatology, plastic surgery, general surgery, podiatry, and otorhinolaryngology. Er:YAG handpiece indicated for superficial skin ablation, dermabrasion, and wrinkle treatment.

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

• LS-40 CO2 Laser System (K093793)
• MLT Erbium:YAG Laser System (K032599)

Submission Summary (Full Text)

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#### Attachment 5 510(K) Summary Cortex CO2 / Er:YAG Laser System

# K110897

JUL - 1 2011

This 510(K) Summary of safety and effectiveness for the Cortex CO2 / Er:YAG Laser System 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: | Sandstone Medical Technologies, LLC | | Sandstone Medical<br>Technologies LLC Cortex<br>CO2 / Er:YAG-Laser System | Sandstone Medical<br>Technologies LLC CO2 Laser<br>(Predicate Device) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Address: | 105 Citation Court<br>Birmingham, AL 35209 | Laser type | Sealed-off CO2 laser tube | Sealed-off CO2 laser tube |
| Contact Person: | Mark Rohrer | Wavelength | 10.6 micron (10,600nm) | 10.6 micron (10,600nm) |
| Telephone:<br>Email: | 205-290-8251 - phone<br>[e-mail] | Power to tissue | 0.5 -40 W | 0.5 -40 W |
| Preparation Date: | March 19, 2011 | Super pulse peak<br>power | 500W | 500W |
| Device Trade Name: | Cortex CO2 / Er:YAG Laser System | Laser operation<br>modes | CW, Super pulse | CW, Super pulse |
| Common Name: | CO2 Laser<br>Er:YAG Laser | Tissue exposure<br>modes | Continuous, Single Pulse,<br>Repeat Pulse | Continuous, Single Pulse,<br>Repeat Pulse |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878-48 | Aiming beam | 3mW (650nm diode)<br>adjustable | 3mW (650nm diode)<br>adjustable |
| Legally Marketed Predicate<br>Device: | LS-40 CO2 Laser System (K)093793<br>MLT Erbium:YAG Laser System (K)032599 | Articulated arm | 7-joint articulated arm | 7-joint articulated arm |
| Description of the Cortex<br>CO2/Er:YAG Laser System | The Cortex system and controls are contained in a single<br>console. Electrical power is supplied to the console by the<br>facility's power source. The CO2 laser is delivered via an<br>articulated arm that is permanently attached to the console.<br>There is an additional Er: YAG handpiece that attaches to a<br>port on the console and contains the laser cavity in the head<br>of the handpiece. The user interface is a touch screen<br>located on the console. The user activates the laser<br>emission by means of a footswitch. | Working radius | 130cm | 130cm |
| Intended use of the Cortex<br>CO2 / Er:YAG Laser System | The CO2 laser is indicated for coagulation, vaporization,<br>ablation or cutting of soft tissue in dermatology and plastic<br>surgery, general surgery, podiatry and otorhinolaryngology. | Cooling type | Closed loop liquid | Closed loop liquid |
| | The Er:YAG handpiece is designed specifically for<br>superficial skin ablation resulting in skin dermabrasion, and<br>the treatment of wrinkles. In addition this system is intended<br>for coagulation, vaporization, ablation, or cutting of soft<br>tissue (skin) in dermatology, plastic surgery (including<br>aesthetic surgery). | Power input<br>requirements | 110VAC/60Hz or<br>220VAC/50Hz +/- 10% | 110VAC/60Hz or<br>220VAC/50Hz +/- 10% |
| Dimension (Wide) | 34cm | 34cm | | |
| (Depth) | 46cm | 46cm | | |
| (Height) | 96cm | 96cm | | |

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#### Attachment 5 510(K) Summary Cortex CO2 / Er:YAG Laser System

Performance Data: None

. ..

Results of Clinical Study: None

Summary of Technological Characteristics:

## Technical Specifications Comparison for the CO2 Laser (including console specification)

.

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### Attachment 5 510(K) Summary Cortex CO2 / Er:YAG Laser System

## Technical Specifications Comparison for the ER:YAG Laser Handpiece

し

...

| | Sandstone Medical<br>Technologies LLC<br>Cortex CO2 / Er:YAG<br>Laser System | Sandstone Medical<br>Technologies LLC<br>Er:YAG Laser<br>(Predicate) |
|-----------------|------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Wavelength | 2940nm | 2940nm |
| Max Power | 2.4 W | 2.4 W |
| Max Fluence | 8 J/cm2 | 8 J/cm2 |
| Pulse Width | 300 µs | 300 µs |
| Repetition Rate | Up to 10 pulse per second | Up to 10 pulse per second |
| Spot Size | 1.5mm, 3mm, 6mm,<br>9mm | 1.5mm, 3mm, 6mm,<br>9mm |

| Conclusion: | The Cortex CO2 / Er:YAG Laser System is<br>comparable to the predicate device in terms of<br>indications for use, technical specifications, operating<br>performance features, general design. |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Sandstone Medical Technologies, LLC % Mr. Mark Rohrer Managing Member 105 Citation Court Homewood, Alabama 35209

JUL - 1 2011

Re: K110897

Trade/Device Name: Cortex Co2/Er: Y AG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and in plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 18, 2011 Received: May 24, 2011 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 、

Dear Mr. Rohrer:

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. Ilsting 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. Mark Rohrer

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/CDRH/CDRHOffices/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 tollofre and [phone] or [phone] or at its Internet address

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

Sincerely yours.

to

Jk.

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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## Indications for Use

K110892

510(k) Number (if known):

Device Name:

Cortex Co2 / Er:YAG Laser System

The CO2 laser is indicated for coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

The Er: YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

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)

Nel RPO Page 1 of 1
(Division Sign Off) mkn

(Division Sign-6 Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110897