ULTRALIGHT II ND:YAG LASER SYSTEM

K041011 · Sandstone Medical Technologies, LLC · GEX · Dec 14, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041011
• Device Name: ULTRALIGHT II ND:YAG LASER SYSTEM
• Applicant: Sandstone Medical Technologies, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 14, 2004
• Decision: SESE
• Submission Type: Traditional
• 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, telangiectasis, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)

Device Story

UltraLight II Nd:YAG Laser System; laser surgical instrument for dermatology/plastic surgery. System comprises power supply unit with cooling, footswitch, and handpiece. Operator (physician/clinician) selects laser parameters via display panel on power supply; delivers light pulses to treatment area via handpiece upon footswitch activation. Operates at 1064 nm and 532 nm wavelengths to target specific pigments and vascular structures. Clinical benefit includes removal/lightening of tattoos, hair, and vascular/pigmented lesions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nd:YAG laser system; dual wavelength output (1064 nm and 532 nm). System includes power supply, cooling unit, footswitch, and handpiece. Parameters controlled via front display panel. Class II device (21 CFR 878.4810).

Indications for Use

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

• Clear Light Nd:Yag Laser (K003460)
• Medlite Laser System (K970808)
• Medlite Laser System (K983054)
• Medlite Laser System (K011677)

Submission Summary (Full Text)

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## Attachment I 510(K) Summary DEC 1 4 2004 UltraLight II Nd: YAG Laser System

This 510(K) Summary of safety and effectiveness for the UltraLight II Nd: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 |
|------------------------------------|-----------------------------------------------------------------------------------------|
| Address: | Sandstone Medical Technologies LLC<br>516 Scott Street<br>Homewood, AL 35209 USA |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 1-205-290-8251- Phone |
| Preparation Date: | April 15, 2004 |
| Device Trade Name: | UltraLight II Nd:YAG Laser System |
| Common Name: | Nd:YAG Laser System |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device: | Clear Light ™ Nd:Yag Laser K003460<br>Medlite Laser System K970808, K983054 and K011677 |

Description of the UltraLight II Nd:YAG Laser System:

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

Performance Data: Results of Clinical Study:

Conclusion:

The UltraLight II Nd:YAG 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 bandpiece. 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

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

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three diagonal lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

Sandstone Medical Technologies, LLC c/o Ms. Connie White Hoy 908 Stetson Street Woodland, California 95776

Re: K041011

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: October 28, 2004 Received: November 3, 2004

Dear Ms. Hoy:

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 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.

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Page 2 - Ms. Connie White Hoy

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with cation. The FDA finding of substantial equivalence of your device to a legally prerketed 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Macer Sacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C Provost

Celia M. Witten, Ph.D., M.D. 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

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

KO41011 / SCO2

Sandstone Medical Technologies UltraLight II Nd:YAG Device Name:

## Laser System

Indications For Use:

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

Muriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

AND/OR

Prescription Use XX (Part 21 CFR 801 Subpart D) 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)

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