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FDA 510(k)

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

K-Number: K162218 · 2016-11-22

Decision Date2016-11-22
Product CodeMLY
DecisionSubstantially Equivalent

Device Summary

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 is a medical device manufactured by Nuance Medical, LLC. It received FDA 510(k) clearance on 2016-11-22 under approval number K162218. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102?

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Nuance Medical, LLC. The 510(k) number is K162218.

When was Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 approved by the FDA?

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 received FDA 510(k) clearance on 2016-11-22, under approval number K162218.

What company makes Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102?

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 is manufactured by Nuance Medical, LLC.

What is the FDA product code for Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102?

The FDA product code for Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 is MLY.

Other Devices by Nuance Medical, LLC

Related Devices (Code: MLY)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.