Class II — Hyperion Medical
| Recalling firm | Hyperion Medical |
|---|---|
| Registered facility | HYPERION MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece. |
| Product | All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013. |
| Quantity | 3,346 brochures. Quantity not applicable to web site. |
| Distribution | US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA. |
| Initiated | 2013-11-20 |
| Classified | 2014-08-18 |
| Terminated | 2015-05-15 |
| Recall number | Z-2264-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hyperion Medical (Z-2264-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67814/
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