CHEVEUX DIODE LASER SYSTEM

K100893 · Sandstone Medical Technologies, LLC · GEX · Jun 16, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100893
• Device Name: CHEVEUX DIODE LASER SYSTEM
• Applicant: Sandstone Medical Technologies, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cheveux Diode Laser System is intended to be used for Hair Removal, Permanent hair reduction, Treatment for pseudofolliculitis barbae, Treatment of vascular lesions, Treatment of benign pigmented lesions, and Treatment of Leg Veins.

Device Story

The Cheveux Diode Laser System is a surgical laser device used in dermatology and plastic surgery. It consists of a console and a handpiece connected via an umbilical. The system delivers 810 nm wavelength laser light to the target tissue. Energy output is initiated by the operator via a trigger on the handpiece. The device is used by clinicians to perform hair removal, permanent hair reduction, and the treatment of vascular lesions, benign pigmented lesions, leg veins, and pseudofolliculitis barbae. By delivering controlled laser energy, the device targets specific skin and hair structures to achieve the intended therapeutic effects.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Diode laser system; 810 nm wavelength; console and handpiece configuration; umbilical connection; trigger-actuated energy delivery.

Indications for Use

Indicated for hair removal, permanent hair reduction, treatment of pseudofolliculitis barbae, vascular lesions, benign pigmented lesions, and leg veins. Intended for use on all skin types (Fitzpatrick I-VI), including tanned skin.

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

• LightSheer Diode Laser System (K003614)

Submission Summary (Full Text)

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## Attachment 5 510(K) Summary Cheveux Diode Laser System

JUN 1 6 2010 -

K 100893

This 510(K) Summary of safety and effectiveness for the Cheveux Diode Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance conceming the organization and content of a 510(K) summary.

Mr. Mark Rohrer

1-205-356-1172 [e-mail]

April 1, 2010

Diode Laser

Leg Veins

None

None

Sandstone Medical Technologies, LLC Applicant:

Address:

Sandstone Medical Technologies LLC 105 Citation Court Birmingham, AL 35209

Cheveux Diode Laser System

79-GEX, 21 CFR 878-48

Instrument, Surgical, Powered, laser

LightSheer Diode Laser System K003614

Contact Person:

Telephone:

Preparation Date:

Device Trade Name:

Common Name:

Classification Name:

Legally Marketed Predicate Device(s):

Description of the Cheveux Diode Laser System

Intended use of the Cheveux Diode Laser System

Performance Data:

Results of Clinical Study:

Conclusion:

The Cheveux Diode Laser System is substantially equivalent to other existing diode laser systems in commercial distribution for use in Dermatology and Plastic Surgery.

The Cheveux Diode Laser System delivers laser light with an

The Cheveux Diode Laser System is intended to be used for

Hair Removal, Permanent hair reduction, Treatment for pseudofolliculitis barbae, Treatment of vascular lesions, Treatment of benign pigmented lesions, and Treatment of

810 nm wavelength. The system consists of a console and a handpiece connected to the system by an umbilical. Energy output is initiated with trigger on the handpiece.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved 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

JUN 1 6 2010

Re: K100893

Trade/Device Name: Cheveux Diode 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: Class II Product Code: GEX Dated: March 31. 2010

Received: April 01, 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

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Page 2 - Mr. Mark Rohrer

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely vo

N. Melkerson

Mark 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:

ুটি

Cheveux Diode Laser System

The Cheveux Diode Laser System is indicated for: Hair Removal Permanent hair reduction Treatment of vascular lesions Treatment of benign pigmented lesions Treatment of Leg Veins Treatment for pseudofolliculitis barbae

The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin

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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices Page 1 of 1

| 510(k) Number | K100893 |
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