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Prosun International, LLC

US

Last updated May 30, 2026

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
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DUNS Number
621545883

Catalogue (20)

DeviceModel / ReferenceRegistriesClassStatus
ProSun Model 52X
FDA UDI
Class IIActive
ProSun Model 38X
FDA UDI
Class IIActive
ProSun Model 28
FDA UDI
Class IIActive
ProSun Model 32/1
FDA UDI
Class IIActive
ProSun Model 48V6
FDA UDI
Class IIActive
ProSun Model 12
FDA UDI
Class IIActive
ProSun Model 32/1-P
FDA UDI
Class IIActive
ProSun Model 36V
FDA UDI
Class IIActive
ProSun Model 24
FDA UDI
Class IIActive
ProSun Model 32J
FDA UDI
Class IIActive
ProSun Model 36X
FDA UDI
Class IIActive
ProSun Model 42V6
FDA UDI
Class IIActive
ProSun Model 36X-P
FDA UDI
Class IIActive
ProSun Model 42X
FDA UDI
Class IIActive
ProSun Model 48V8-E
FDA UDI
Class IIActive
ProSun Model 32
FDA UDI
Class IIActive
ProSun Model 48V8
FDA UDI
Class IIActive
ProSun Model 24J
FDA UDI
Class IIActive
ProSun Model 42V3
FDA UDI
Class IIActive
ProSun sunlamp products, Luxura sunlamp products K181455
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Dec 10, 2018Z-1177-2019—terminated

ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.

Dec 10, 2018Z-1176-2019—terminated

ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.

Dec 2, 2017Z-0319-2018—terminated

The 30 minute maximum tanning time has been reduced to 20 minutes.