FDA.reportPublic FDA data

510(k) K232674

Device
PainFreeze II
Applicant
Nuance Medical, LLC
510(k) number
K232674
Product code
MLY
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-12
Date received
2023-09-01
Classification name
Vapocoolant Device
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Neal Hartman
Address
5931 Sea Lion Pl. Suite 113 Carlsbad CA US 92010 92010

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K030281CRYOTRON 2 CRYOTHERAPY DEVICECryonic Medical North America2003-08-20
K031036GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03Gebauer Co.2003-07-10