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Lutronic Corporation · Model Operator's Goggle · UDI-DI 08809447652177
ONG
Prescription
10
510(k) clearances
151
Adverse events
4
Recalls
57
Facilities
Description
Operator's Goggle for DENTA II
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-16 | IDS LTD | The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device. |
| 2024-08-23 | WINGDERM ELECTRO-OPTICS LTD. | Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances |
| 2014-03-20 | Solta Medical, Inc. | Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma. |
| 2010-12-15 | Solta Medical, Inc. | The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs. |
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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.