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Osstem Implant Co.,Ltd.

Osstem Implant Co.,Ltd. · Model BeauTis Light S · UDI-DI 08800000995762

EEG Prescription
10
510(k) clearances
85
Adverse events
0
Recalls
118
Facilities

Description

The BeauTis Light S is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect. The BeauTis Light S is a medical device that must be operated by medical personnel. The BeauTis Light S is classifiled as Class ll and Type BF applied part. The nornal maximum operation condition is 20 min operation, 5 min rest for BeauTis Light S

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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.