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MoleScope Lite

MetaOptima Technology Inc · Model 850147000094 · UDI-DI 00850147000094

IBJ
9
510(k) clearances
4
Adverse events
2
Recalls
52
Facilities

Description

MoleScope™Lite is a handheld magnifier intended for examining intact skin, nail and hair by laypersons and healthcare professionals. Optionally, MoleScope™ Lite can be attached to a smartphone or tablet to capture digital images within the specifications of the mobile device.

Recalls

DateFirmReason
2013-12-20Zeiss, Carl IncCarl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.
2013-05-28Zeiss, Carl IncCarl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambd

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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.