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Luxe™ 2.5 Semi-custom loupe

METREX RESEARCH, LLC · Model 922464-2 · UDI-DI 00850036373469

FSP
4
510(k) clearances
10
Adverse events
3
Recalls
62
Facilities

Description

Luxe™ 2.5 Semi-custom loupe demo bag with 9 demo loupes: Model No. DI Number Device Description 922537-1 00850036373377 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, short WD, demo only 922537-2 00850036373384 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, regular WD, demo only 922537-3 00850036373391 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, long WD, demo only 922538-1 00850036373407 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, short WD, demo only 922538-2 00850036373414 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, regular WD, demo only 922538-3 00850036373421 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, long WD, demo only 922539-1 00850036373438 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, short WD, demo only 922539-2 00850036373445 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, regular WD, demo only 922539-3 00850036373452 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, long WD, demo only

Recalls

DateFirmReason
2025-07-03Orascoptic Surgical AcuityDue to complaints, loupe nose pads containing nickel may cause an allergic reaction.
2025-07-03Orascoptic Surgical AcuityDue to complaints, loupe nose pads containing nickel may cause an allergic reaction.
2012-04-10Kerr CorporationThe firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to speci

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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.