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SIRONA

Wuhan Dimed Laser Technology Co., Ltd. · Model SIRONA 100 · UDI-DI 06974214160802

PDZILY Prescription
10
510(k) clearances
3
Adverse events
1
Recalls
18
Facilities

Description

The SIRONA 100 utilizes a solid-state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via flexible fiber connected at one end to the laser source and the other end to the Handpiece. The device is activated by means of a footswitch or a finger switch on the handpiece.

Recalls

DateFirmReason
2013-11-20Hyperion MedicalBrochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.