VIKINI Diode Laser System

K151232 · Ilooda Co,., Ltd. · GEX · Aug 6, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K151232
• Device Name: VIKINI Diode Laser System
• Applicant: Ilooda Co,., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VIKINI DIODE LASER SYSTEM is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Device Story

VIKINI DIODE LASER SYSTEM is a diode laser device used for hair removal, permanent hair reduction, and treatment of benign vascular and pigmented lesions. Device operates by delivering laser energy to target tissues; used in clinical settings by trained healthcare professionals. Output consists of controlled laser pulses; provider uses output to achieve therapeutic tissue effects. Benefits include non-invasive reduction of unwanted hair and treatment of skin lesions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Diode laser system; intended for dermatological applications. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for hair removal, permanent hair reduction, and treatment of benign vascular and pigmented lesions in patients seeking 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 Center - WO66-G609 Silver Spring, MD 20993-0002

August 6, 2015

ILOODA Company, Ltd. % Mr. Kevin Walls Regulatory Insight Incorporated 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K151232

Trade/Device Name: VIKINI 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: May 7, 2015 Received: May 8, 2015

Dear Mr. Walls:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director

For

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K151232

Device Name VIKINI DIODE LASER SYSTEM

## Indications for Use (Describe)

The VIKINI DIODE LASER SYSTEM is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt; "><span style="font-family: Arial;">Prescription Use (Part 21 CFR 801 Subpart D)</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span> </span> | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Arial;">Over-The-Counter Use (21 CFR 801 Subpart C)</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span> </span> |

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