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ET LightSheer 1060 and High Speed LightSheer 1060 are intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for hair removal, permanent hair reduction, and the treatment for Pseudofolliculitis Barbae (PFB ).

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

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, café-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions.

ET LightSheer 1060 and High Speed LightSheer 1060 are also intended for treatment of wrinkles.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The ET LightSheer 1060 and High Speed LightSheer 1060 are two treatment handpieces, intended to be used with Lumenis LightSheer Duet Laser System.

One handpiece is the ET LightSheer 1060 handpiece, which delivers laser energy through a 9 x 9 mm tip up to 90 J maximum. The settings for this handpiece are selectable pulse duration from 5 - 400 ms, selectable fluence from 10 - 100 J/cm2 and a pulse repetition rate up to 3 Hz maximum.

The second handpiece is the High Speed LightSheer 1060 handpiece, which delivers laser energy from a 22 x 35 mm diode array up to 93 J maximum. The settings for this handpiece are pulse duration from 10 - 100ms, selectable fluence from 4.5 - 12 J/cm2 and multiple pulsing up to 3 pulses.

The ET LightSheer 1060 handpiece tip is water-cooled to provide active skin cooling. The High Speed LightSheer 1060 handpiece tip uses vacuum and lower laser energy densities which reduce skin heating.

This 510(k) summary for the Lumenis ET LightSheer 1060 and High Speed LightSheer 1060 describes the device's technical characteristics and claims substantial equivalence to predicate devices, but does not provide details of a specific clinical study with acceptance criteria and results in the way typically expected for a device proving performance against set criteria.

Instead, the submission relies on demonstrating substantial equivalence through:

• Same intended use, principles of operation, and mechanism of action as previously cleared predicate devices.
• Equivalent performance characteristics to predicate devices.
• Identical materials and manufacturing methods to a previously cleared Lumenis device (K053628).
• Conformity to established electrical and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, and IEC 60825-1).

Therefore, I cannot populate a table of acceptance criteria and reported device performance from the provided text, nor can I answer many of the specific questions about clinical study design. There is no mention of sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods for clinical performance. Similarly, no multi-reader multi-case (MRMC) or standalone algorithm performance studies are described.

The "Testing" section focuses on bench testing and compliance with safety standards, rather than clinical performance studies against specific acceptance criteria. The "Conclusion" explicitly states that the evaluation "does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device," indicating that the submission primarily leveraged the predicate device framework for clearance.

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