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Primo Dental Laser
MEDENCY SRL · Model Primo Komfort · UDI-DI 08059340290024
1
510(k) clearances
5
Adverse events
2
Recalls
19
Facilities
Description
Max power: 7W Wavelength: 810nm The model Primo Komfort of the family of medical devices "Primo Dental Laser" is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It’s a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-01 | Convergent Dental | It has been found that potential unintended laser activation can occur without foot pedal depression. |
| 2008-08-08 | Zap Lasers LLC | The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures a |
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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.