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MoleScope II
MetaOptima Technology Inc · Model 850147000087 · UDI-DI 00850147000087
6
510(k) clearances
10
Adverse events
1
Recalls
159
Facilities
Description
MoleScope is a battery-powered dermatoscope intended to be attached to smartphones and tablets to take images of skin, scalp, hair, nail, and other body surfaces with high magnification and cross-polarized light. It is a reusable, non-invasive device for imaging and documentation only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-20 | DermLite LLC | Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling. |
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Get your free API keyRead the docsData 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.