BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP

K063060 · Blueshine Srl · GEX · Nov 29, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063060
• Device Name: BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP
• Applicant: Blueshine Srl
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Blueshine Light Shine is intended for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions and inflammatory acne (acne vulgaris) It can be used for all skin types, from I (subjects with white skin, freckles, blond or red hair, blue or green eyes) to VI (subjects with brown to dark skin/ brown or black hair/ brown eyes included suntanned skin).

Device Story

Blueshine Light Shine system is a pulsed light device for dermatological applications. System features adjustable wavelength range and selectable handpiece aperture sizes. Operator activates light emission via foot switch. Device weighs 110lbs and measures 57x56x98cm. Operates on 110 VAC. Used in clinical settings by healthcare professionals. Device delivers light energy to target tissues to achieve photothermolysis or photocoagulation. Clinical benefit includes hair reduction, vascular lesion treatment, and acne management.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Pulsed light system with adjustable wavelength range. Features selectable handpiece aperture sizes. Electrical requirements: 110 VAC, 16A, 50-60 Hz, single phase. Foot switch activation. Dimensions: 57x56x98cm. Weight: 110lbs.

Indications for Use

Indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of facial/leg veins, treatment of benign pigmented lesions, and inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

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

• Radiancy (Israel) Ltd Skinstation system (K030897)
• Sciton, Inc. Profile BBL system (K032460)

Submission Summary (Full Text)

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K063060

## 510(k) Summary

| Submitter: | Blueshine Sr.l. -- Unipersonale<br>Via Olivi, 2<br>30171 Mestre<br>VE/Italy<br>Ph. 0039 041 5055847 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NOV 2 9 2006 |
| Facility description: | Placed on 500 m², Blueshine Company is divided<br>in accounting, commercial and technical<br>departments, wares receipt and storage areas,<br>warehouse, hydraulic, electronic, optical<br>assembly areas, final test area and shipping<br>division. The production, for some part, is in<br>outsourcing, receiving half-assemblied and<br>assemblied products from its suppliers. |
| Contact: | Ms. Alice Novelli<br>Quality and Certification Dept. |
| Date Summary Prepared: | May 23, 2006 |
| Device Trade Name: | Blueshine Light Shine system |
| Common Name: | Pulsed Light System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.410 |
| Equivalent Device: | Radiancy (Israel) Ltd Skinstation system, cleared<br>for commercial distribution by the FDA on June<br>19, 2003 under 510(k) notification No. K030897<br>and Sciton, Inc. Profile BBL system cleared for<br>commercial distribution by the FDA on November<br>11, 2003 under 510 (k) notification No. K032460 |
| Device Description: | The Blueshine Light Shine System is a pulsed<br>light, wavelength range adjustable system. It<br>provides selectable handpiece aperture sizes for<br>a variety of applications |
| | Light emission activation is by foot switch.<br>Overall weight of the system is 110lbs., and the<br>size is 57x56x98cm (LxWxH). |
| | Electrical requirement is 110 VAC, 16A, 50-60<br>Hz, single phase. |

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| Intended Use: | The Blueshine Light Shine is intended for<br>permanent hair reduction, photocoagulation of<br>dermatological vascular lesions,<br>photothermolysis of blood vessels (treatment of<br>facial and leg veins), and treatment of benign<br>pigmented lesions and inflammatory acne (acne<br>vulgaris)<br>It can be used for all skin types, from I (subjects<br>with white skin, freckles, blond or red hair, blue<br>or green eyes) to VI (subjects with brown to<br>dark skin/ brown or black hair/ brown eyes<br>included suntanned skin). |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | The Blueshine Light Shine system has similar<br>indications for use, the same principle of<br>operation, and essentially the same wavelength<br>range and pulse energy range as the predicate<br>devices. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Blueshine Light Shine system is a safe and<br>effective device for the indicated uses. |
| Additional Information: | none |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Blueshine SRL c/o Mark Job Regulatory Technology Scrvices, Inc. 1394 25th Street, NW Buffalo, MN 55313

NOV 2 9 2006

Re: K063060

Trade/Device Name: Blueshine Light Shine Systems: SP, Twin, and Compact SP Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: Class II Product Code: GEX Dated: November 13, 2006 Received: November 14, 2006

Dear Mr. Job:

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

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## Page 2 - Mr. Mark Job

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 Office of Compliance at (240) 276- 0115. 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 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 your

Pa. M

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Blueshine Light Shine systems; SP, Twin and Compact SP

Indications For Use:

The Blueshine Light Shine system is Indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photermolysis of blood vessels (treatment of facial and leg velns), and treatment of benign pigmented leslons.

It is also indicated for treatment of inflammatory acne (acne vulgaris).

Prescriptive Use_ x OR (Part 21 CFR 801 Subpart D)

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

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Concurrence of CDRH, office of Device Evaluation (ODE)

(Division Sign-Off Division of Generaly-Restorative, FR +30.41 606547 + FR +30.01 16820 + Blacker (2008) 1982) 2007 1982 1000 19620 1982 1983 1983 1983 1983 1983 1983 1983 1983 1983 1983 1983 1 and Neurological Devices

**510(k) Number** K063060