SMOOTHCOOL

K092326 · Jeisys Medical, Inc. · ONF · Mar 5, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K092326
• Device Name: SMOOTHCOOL
• Applicant: Jeisys Medical, Inc.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Mar 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The left handpiece (560nm) of the SmoothCool is indicated for the treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benigh vascular lesions (diffuse redness). The right handpiece (700nm) is indicated for hair removal (permanent hair reduction).

Device Story

SmoothCool is a laser surgical instrument for dermatology. Device utilizes two distinct handpieces: 560nm wavelength for benign pigmented and vascular lesions; 700nm wavelength for permanent hair reduction. Operated by clinicians in a clinical setting. Device delivers light energy to target tissues to achieve therapeutic effects. Output allows for non-invasive dermatological procedures. Benefits include reduction of skin lesions and hair growth.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison to predicate devices.

Technological Characteristics

Laser surgical instrument; Class II; Product Code ONF. Features two handpieces with specific wavelengths: 560nm and 700nm. Energy source: Laser. Intended for dermatological applications.

Indications for Use

Indicated for treatment of benign pigmented lesions (solar lentigines, ephilides, mottled pigmentation), benign vascular lesions (diffuse redness), and permanent hair reduction in patients requiring dermatological laser therapy.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JM Systems Co. Ltd. % Regulatory Insight, Inc. Mr. Kevin Walls, RAC 5401 South Cottonwood Court Greenwood Village, Colorado 80121

## MAR - 5 2010

Re: K092326

Trade/Device Name: Smoothcool 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: ONF Dated: March 3, 2010

Received: March 4, 2010

Dear Mr. Walls:

We have reviewed your Section 5 1 0(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 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

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Page 2 - Mr. Kevin Walls, RAC

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 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.

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.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson 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): K09 2326

Device Name: SmoothCool

The left handpiece (560nm) of the SmoothCool is indicated for the treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benigh vascular lesions (diffuse redness). The right handpiece (700nm) is indicated for hair removal (permanent hair reduction).

Prescription Use × (Part 21 CFR 801 Subpart D)

الموالي المتحدة المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المن

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nilford Ode Carmen

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

510(k) Number K092326

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