LS-40 CO2 LASER SYSTEM MODEL LS-40

K093793 · Sandstone Medical Technologies, LLC · GEX · Feb 18, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093793
• Device Name: LS-40 CO2 LASER SYSTEM MODEL LS-40
• Applicant: Sandstone Medical Technologies, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 18, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

Device Story

LS-40 CO2 Laser System is a microprocessor-controlled surgical laser; utilizes sealed CO2 laser tube within main cabinet; features articulated arm beam delivery system and attachable accessories. Device activated via footswitch; delivers maximum 40 watts power. Used in clinical settings (dermatology, plastic surgery, general surgery, podiatry, otorhinolaryngology) by physicians for soft tissue management (coagulation, vaporization, ablation, cutting). Output is laser energy directed at target tissue to achieve surgical effect. Benefits include precise tissue interaction for various surgical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Microprocessor-controlled CO2 laser system; sealed CO2 laser tube; articulated arm beam delivery system; 40W maximum power output; footswitch activation; Class II device.

Indications for Use

Indicated for coagulation, vaporization, ablation, or cutting of soft tissue in dermatology, plastic surgery, general surgery, podiatry, and otorhinolaryngology.

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-25 Family of CO2 Laser Systems (K040563)

Submission Summary (Full Text)

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Attachment V Special 510(K) Summary LS-40 CO2 Laser System

K093793

FEB 1 8 2010

The system

This 510(K) Summary of safety and effectiveness for the LS-40 CO2 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.

Mark Rohrer

CO2 Laser

footswitch.

None

None

105 Citation Street

Homewood, AL 35209

205-290-8251 - phone

[e-mail]

LS-40 CO2 Laser System

79-GEX, 21 CFR 878-48

and otorhinolaryngology.

Instrument, Surgical, Powered, laser

LS-25 Family of CO2 Laser Systems K040563

providing 40 watts maximum power.

The LS-40 CO2 Laser System is a microprocessor-

controlled CO2 laser system using a sealed CO2 laser tube

incorporates a CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The unit is activated for laser emission by a

The LS-40 CO2 Laser System is intended to be used for

Coagulation, Vaporization, Ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry

December 2, 2009

Sandstone Medical Technologies, LLC Applicant:

Address:

Contact Person:

Telephone and Email:

Preparation Date:

Device Trade Name:

Common Name:

Classification Name:

Legally Marketed Predicate Device:

Description of the Enlyten System

Intended use of the Enlyten System:

Performance Data: Results of Clinical Study:

Conclusion:

The LS-40 CO2 Laser System is substantially equivalent to the previously cleared LS Family of CO2 Lasers that is in commercial distribution for use in Dermatology and Plastic Surgery.

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

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 105 Citation Court Homewood, Alabama 35209

FEB 1 8 2010

Re: K093793

Trade/Device Name: LS-40 CO2 Surgical 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: GEX Dated: January 18, 2010 Received: January 19, 2010

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, 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manutacturing practice requirements as set

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Page 2 - Mr. Mark Rohrer

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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

FOR

Sincerely yours.

M. N. McMillen

ACTING
DBORD DIR.

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

510(k) Number (if known): _

Device Name:

Indications for Use:

Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

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)

Michael P. O'Leary FOR M. MELKERSON

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

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510(k) Number K093793