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The 21tt Century Centurion ExceLED and System Two LED lights are intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures.

The System Two LED surgical Lighting System is an AC powered device which provides a focusable filed of illumination for general examination and surgery.

It can consist of any combination of the 3 lights (D1, D2, D3) listed below.

All 3 models will have 5-level dimming and beam size (8"-12") adjustments.

D1 = small minor surgical light / satellite

• D2 = large minor surgical light
  D3 = major surgical light

The proposed 21* Century Centurion ExceLED (an AC powered device) is the first generation fixed pattern / five level intensity minor surgical LED (Light Emitting Diode) light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.

The proposed System Two LED surgical Lighting System is an AC powered device which provides a focusable field of illumination for general examination and surgery. It can consist of any combination of the 3 lights (D1, D2, D3) listed below.

All 3 models will have 5-level dimming and beam size (8"-12") adjustments.

• D1 = small minor surgical light / satellite
• D2 = large minor surgical light
• D3 = major surgical light

The provided document is a 510(k) summary for a surgical lighting system and does not contain information about acceptance criteria for a device, nor a study proving meeting such criteria. Instead, it details the device's description, intended use, safety information, and substantial equivalence to predicate devices, focusing on regulatory approval for market entry.

Therefore, I cannot provide the requested information.

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