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Rochester Optical

Vision Associates Of Rochester, Inc. · Model RO-ML2-KIT · UDI-DI 00860010085615

510(k) clearances

Adverse events

Recalls

Facilities

Description

The registered product is a lens kit, which includes EIGHT (8) inserts in pre-determined diopters (+1.50D, -1.0D, -1.50D, -2.0D, -2.50D. -3.0D, -4.0D, and -5.0D) with a pupillary distance of 65mm. They are not made to any user’s prescription. Their intent is to provide wearers of Magic Leap 2 smart glasses with a quick vision solution, typically in a demo or tradeshow scenario. The product is exclusively designed to work with Magic Leap 2 smart glasses to help prescription eyeglasses wearers to view the augmented reality display with corrective lenses

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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.