FDA Device Intelligence
Home › QUANTA SYSTEM SPA › Hyperblue plus

Hyperblue plus

QUANTA SYSTEM SPA · Model PDMS00246 · UDI-DI 08033945934347

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

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

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.