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Lunula
ERCHONIA CORPORATION, LLC · Model FFS · UDI-DI 00858985006056
PDZ
Prescription
10
510(k) clearances
3
Adverse events
1
Recalls
18
Facilities
Description
MEDICAL - Floor Model Low Level Laser - 2 diodes 635nm & 405nm - IFU Reduction Onychomycosis
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-11-20 | Hyperion Medical | Brochures 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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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.