LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE

K082101 · Sandstone Medical Technologies, LLC · GEX · Nov 5, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082101
• Device Name: LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
• Applicant: Sandstone Medical Technologies, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The scanning handpiece is intended to be used as an accessory to the LS Family of CO2 Lasers to deliver the laser light to the targeted area for skin resurfacing in a fractionated manner.

Device Story

The LS Family of CO2 Lasers with scanning handpiece is a microprocessor-controlled surgical laser system. The device delivers CO2 laser energy to targeted skin tissue in a scanned, fractionated pattern. It is intended for use by clinicians for skin resurfacing procedures. The system utilizes a handpiece to control the delivery of laser light, allowing for precise energy application. The output affects tissue by facilitating resurfacing, which can benefit patients through dermatological improvement. The device operates under clinician control in a clinical setting.

Clinical Evidence

No formal clinical trial data provided. Histology was collected from a small sample of patients to determine the depth of penetration of the laser energy.

Technological Characteristics

Microprocessor-controlled CO2 laser system; utilizes a scanning handpiece for fractionated energy delivery. Operates as a surgical laser instrument (21 CFR 878.4810).

Indications for Use

Indicated for skin resurfacing in patients requiring dermatological laser treatment. Prescription use only.

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 Family of CO2 Lasers (K040563)

Submission Summary (Full Text)

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## Attachment III 510(K) Summary LS Family of CO2 Lasers with Fractionated Handpiece

082101

This 510(K) Summary of safety and effectiveness for the LS Family of CO2 Lasers is submitted in accordance with the requirements of the SMDA 1990 and the following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Sandstone Medical Technologies, LLC |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Sandstone Medical Technologies, LLC<br>105 Citation Court<br>Homewood, Alabama 35209 |
| Contact Person: | Mark Rohrer |
| Telephone: | 1-205-290-8251- Phone |
| Preparation Date: | July 20, 2008 |
| Device Trade Name: | LS Family of CO2 Lasers |
| Common Name: | CO2 Laser |
| Classification Name: | Instrument, Surgical, Powered, laser 79-GEX,<br>21 CFR 878-48 |
| Equivalent Device: | LS Family of CO2 Lasers cleared under K040563 |
| Description of the LS Family System: | The LS Family of CO2 lasers are microprocessor-<br>controlled laser systems that incorporate a handpiece to<br>deliver energy to the tissue in a scanned, fractionated<br>pattern. |
| Intended Use: | The scanning handpiece is intended to be used as an<br>accessory to the LS Family of CO2 Lasers to deliver the<br>laser light to the targeted area for skin resurfacing in a<br>fractionated manner. |
| Performance Data: | None |
| Results of Clinical Study: | Histology was collected from a small sample of patients<br>to determine the depth of penetration. |
| Conclusion: | The LS Family of CO2 Lasers with the additional<br>scanning handpiece is substantially equivalent to the<br>previously cleared LS Family of CO2 Lasers. |

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

NOV - 5 2008

Re: K082101

Trade/Device Name: Sandstone Medical Technologies Family of LS CO2 Lasers with Scanning Handpiece 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: September 24, 2008 Received: September 29, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html,

Sincerely yours,

Mark N. Millman

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

Enclosure

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Indications for Use

## KO82101 510(k) Number (if known): K Pending

Device Name:

Sandstone Medical Technologies Family of LS CO2 Lasers with Scanning Handpiece

Skin Resurfacing

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082101