(55 days)
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).
The Blueshine Light Shine System is a pulsed light, wavelength range adjustable system. It provides selectable handpiece aperture sizes for a variety of applications Light emission activation is by foot switch. Overall weight of the system is 110lbs., and the size is 57x56x98cm (LxWxH). Electrical requirement is 110 VAC, 16A, 50-60 Hz, single phase.
The provided 510(k) summary for the Blueshine Light Shine system indicates that no clinical performance data or nonclinical performance data were submitted to demonstrate the device meets acceptance criteria.
The submission relies on a claim of "substantial equivalence" to predicate devices (Radiancy (Israel) Ltd Skinstation system, K030897, and Sciton, Inc. Profile BBL system, K032460) based on similar indications for use, principle of operation, wavelength range, and pulse energy range.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document, as such information was not provided in the 510(k) submission.
Summary of unavailable information:
- Table of acceptance criteria and reported device performance: Not provided. The submission states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."
- Sample size used for the test set and data provenance: Not applicable as no performance studies were submitted.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not done/reported.
- Standalone (algorithm only) performance study: Not applicable as this is a physical device, and no algorithm-only performance was assessed.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable as no studies involving training sets were reported.
- How the ground truth for the training set was established: Not applicable.
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510(k) Summary
| Submitter: | Blueshine Sr.l. -- UnipersonaleVia Olivi, 230171 MestreVE/ItalyPh. 0039 041 5055847 |
|---|---|
| NOV 2 9 2006 | |
| Facility description: | Placed on 500 m², Blueshine Company is dividedin accounting, commercial and technicaldepartments, wares receipt and storage areas,warehouse, hydraulic, electronic, opticalassembly areas, final test area and shippingdivision. The production, for some part, is inoutsourcing, receiving half-assemblied andassemblied products from its suppliers. |
| Contact: | Ms. Alice NovelliQuality 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, laser79-GEX21 CFR 878.410 |
| Equivalent Device: | Radiancy (Israel) Ltd Skinstation system, clearedfor commercial distribution by the FDA on June19, 2003 under 510(k) notification No. K030897and Sciton, Inc. Profile BBL system cleared forcommercial distribution by the FDA on November11, 2003 under 510 (k) notification No. K032460 |
| Device Description: | The Blueshine Light Shine System is a pulsedlight, wavelength range adjustable system. Itprovides selectable handpiece aperture sizes fora variety of applications |
| Light emission activation is by foot switch.Overall weight of the system is 110lbs., and thesize is 57x56x98cm (LxWxH). | |
| Electrical requirement is 110 VAC, 16A, 50-60Hz, single phase. |
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| Intended Use: | The Blueshine Light Shine is intended forpermanent hair reduction, photocoagulation ofdermatological vascular lesions,photothermolysis of blood vessels (treatment offacial and leg veins), and treatment of benignpigmented lesions and inflammatory acne (acnevulgaris)It can be used for all skin types, from I (subjectswith white skin, freckles, blond or red hair, blueor green eyes) to VI (subjects with brown todark skin/ brown or black hair/ brown eyesincluded suntanned skin). |
|---|---|
| Comparison: | The Blueshine Light Shine system has similarindications for use, the same principle ofoperation, and essentially the same wavelengthrange and pulse energy range as the predicatedevices. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Blueshine Light Shine system is a safe andeffective 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 (800) 638-2041 or (240) 276-3150 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)
(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 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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.