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Fast Metal
Minami Medical Technology (Guangdong) Co., Ltd. · Model FMi32BKSMS1 · UDI-DI 06972075360010
10
510(k) clearances
50
Adverse events
1
Recalls
1,429
Facilities
Description
sunglasse consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-11-24 | Luxottica | The lenses made for sunglass frames (Liberty Sport Slam or MaxMorpheus) do not meet the lens thickness specification established by the frame manufacturer. The lens thickness rang |
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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.