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510(k) K162218

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 by Nuance Medical, LLC — Product Code MLY

K162218 is an FDA 510(k) premarket notification submitted by Nuance Medical, LLC for the device "Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102". The FDA issued a decision of Substantially Equivalent on November 22, 2016. The device falls under product code MLY (Vapocoolant Device), a Class U device. Nuance Medical, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2016
Date Received
August 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vapocoolant Device
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

Other clearances by Nuance Medical, LLC

  • K232674 — PainFreeze II (February 12, 2024)
  • K210310 — CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit (October 22, 2021)
  • K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (October 18, 2017)
  • K161337 — CryoDose H or Similar (July 12, 2016)
  • K130995 — NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY (June 14, 2013)

Other clearances for product code MLY

  • K261684 — FreezeSpray TA (September 5, 2026)
  • K260870 — Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium S (August 27, 2026)
  • K243654 — DentalJect (May 30, 2025)
  • K232674 — PainFreeze II (February 12, 2024)
  • K203661 — CRYO Arctic, CRYO Penguin (May 25, 2022)
  • K202782 — num Vapocoolant (December 21, 2020)
  • K201248 — Syringe Holder accessory (August 12, 2020)
  • K193349 — Vapocoolshot Mist (April 14, 2020)
  • K190161 — Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chlo (May 7, 2019)
  • K172598 — Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic (April 19, 2018)

FDA data resources