Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102

Refrigerant, Topical (vapocoolant)

NUANCE MEDICAL, LLC

The following data is part of a premarket notification filed by Nuance Medical, Llc with the FDA for Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102.

Pre-market Notification Details

• Device ID: K162218
• 510k Number: K162218
• Device Name: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
• Classification: Refrigerant, Topical (vapocoolant)
• Applicant: NUANCE MEDICAL, LLC 5931 Sea Lion Place, Suite 113 Carlsbad, CA 92008
• Contact: Marc Lieberman
• Correspondent: Marc Lieberman; NUANCE MEDICAL, LLC 5931 Sea Lion Place, Suite 113 Carlsbad, CA 92008
• Product Code: MLY
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-08
• Decision Date: 2016-11-22
• Summary: summary