MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM

K082407 · Sandstone Medical Technologies, LLC · GEX · Feb 3, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082407
• Device Name: MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
• Applicant: Sandstone Medical Technologies, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 3, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions . and the removal or lightening of hair. At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)

Device Story

UltraLight II Nd:YAG Laser System; consists of power supply unit with cooling, footswitch, and handpiece. Operates at 1064 nm and 532 nm wavelengths. Physician-operated in clinical settings. User controls laser parameters via display panel on power supply; delivers light pulses to treatment area upon footswitch activation. Used for dermatological procedures including tattoo removal, vascular lesion treatment, and hair removal. Provides targeted laser energy to specific tissue types to achieve therapeutic outcomes.

Clinical Evidence

No clinical data.

Technological Characteristics

Nd:YAG laser system; dual wavelength (1064 nm and 532 nm); includes power supply unit, cooling system, footswitch, and handpiece. Operates as a surgical laser instrument.

Indications for Use

Indicated for patients requiring removal of dark ink tattoos, red ink tattoos, pigmented lesions (e.g., lentigines, ephelides), vascular lesions (e.g., facial/leg veins, telangiectasias, angiomas, hemangiomas, port wine stains), or hair removal/lightening.

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

• UltraLight II Nd:YAG Laser System (K041011)

Submission Summary (Full Text)

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#### Attachment I Special 510(K) Summary UltraLight II Nd: Y AG Laser System

082407

FEB - 3 2009

This 510(K) Summary of safety and effectiveness for the UltraLight II Nd:Y AG 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:

Address:

Sandstone Medical Technologies, LLC

Sandstone Medical Technologies LLC 516 Scott Street Homewood, AL 35209 USA

Mr. Mark Rohrer

1-205-290-8251- Phone

August 20, 2008

UltraLight II Nd: YAG Laser System

Nd:YAG Laser System

Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48

UltraLight II Nd:YAG Laser System K041011

The UltraLight II Nd: Y AG Laser System consists of a power supply unit with cooling, a footswitch and an umbilical cord that connects to the laser, which is located in the handpiece. In standard use, the handpiece is held against the treatment area dn the light pulse is delivered when the footswitch is depressed. Laser parameters and other system features are controlled from the display panel located on the front of the power supply unit.

At the 1064 nm wavelength - dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.

At the 532 nm wavelength - removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasis, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)

None None

The UltraLight II Nd:YAG laser system is substantially equivalent to other existing Nd:YAG Laser Systems in commercial distribution for use in Dermatology and Plastic Surgery.

Contact Person:

Telephone:

Preparation Date:

Device Trade Name:

Common Name:

Classification Name:

Legally Marketed Predicate Device:

Description of the UltraLight II Nd:YAG Laser System:

Intended use of the UltraLight II Nd: Y AG Laser System:

:

Performance Data: Results of Clinical Study:

Conclusion:

ri

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Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract image of an eagle, represented by a series of curved lines and shapes. The eagle is facing to the right.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

FEB - 3 2009

Re: K082407

Trade/Device Name: Sandstone Medical Technologies UltraLight II Nd: YAG 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 13, 2009 Received: January 14, 2009

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. Iisting 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 vours.

Mark N Milliman

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

# 68240

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

Device Name:

Sandstone Medical Technologies UltraLight II Nd:YAG

Laser System

Indications For Use:

- At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions . and the removal or lightening of hair.
- At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions � including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)

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 Ballaton (ODE) Division of General, Restorative,

and Neurological Devices

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