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Spot-On 2 LED Headlight

PRACTICON, INC. · Model 08264B · UDI-DI 00723896008645

510(k) clearances

Adverse events

Recalls

Facilities

Description

Illuminate the oral cavity without blinding your patient. Spring clip mount fits most eyewear. Loupe mount also included. Continuously adjustable spot size, from 0.6" dia. to 3" dia. at a working distance of 14". XY-adjustable light mount directs illumination exactly where you need it. Eight brightness levels to suit varying lighting needs. Long-lasting LED bulb provides crisp, white light. Sharp, circular focus eliminates perimeter "halos." Weighs only 0.8 oz. (without cord or battery). Specifications: Operating time: 2-1/2 hours on one six-hour charge. Spot diameter: 0.6"-3" at 14" working distance. Lamp weight: 0.8 oz. (without cord or battery). Light intensity: adjustable up to 23,000 lux. Color temp.: 6,000K (±1,000). Battery: 2,600mAh rechargeable Lithium. System includes 5V charger, spring clip mount, loupe mount, two battery packs, clip-on leather battery case, cord clips, and padded storage case. One year warranty.

Recalls

Date	Firm	Reason
2014-06-11	Integra LifeSciences Corp.	LED battery chargers may prematurely fail and will not charge the LED battery as intended

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.