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Hyperion Medical

United Statesfrom the FDA registration address FDA establishment FEI 3007674911

Devices
0
Registrations
FDA
FDA recalls
1

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
3007674911
Address
15932 MIDWAY RD, ADDISON, TX, 75001

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2013

    • 20 Nov 2013 Z-2264-2014 Class II Terminated 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. Distribution: US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.

This is an FDA establishment record without devices in deviCERTS.