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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:

1. Table of acceptance criteria and reported device performance: Not provided. The submission states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."
2. Sample size used for the test set and data provenance: Not applicable as no performance studies were submitted.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not done/reported.
6. Standalone (algorithm only) performance study: Not applicable as this is a physical device, and no algorithm-only performance was assessed.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as no studies involving training sets were reported.
9. How the ground truth for the training set was established: Not applicable.

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