Refrigerant, Topical (vapocoolant)

Device Code: 5252

Product Code(s): MLY

Device Classification Information

• Device Type ID: 5252
• Device Name: Refrigerant, Topical (vapocoolant)
• Review Panel: Physical Medicine
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Physical Medicine And Rehabilitation Devices Branch (PMDB)
• Submission Type: 510(k)
• FDA Device Classification: Class Unclassified Medical Device
• Product Code: MLY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5252
• Device: Refrigerant, Topical (vapocoolant)
• Product Code: MLY

Premarket Reviews
Manufacturer	Decision
GEBAUER CO.
	SUBSTANTIALLY EQUIVALENT	1
NUANCE MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Adverse Event Without Identified Device Or Use Problem	4
Total Device Problems	4

TPLC Last Update: 2019-04-02 21:03:02