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510(k) K232674

PainFreeze II by Nuance Medical, LLC — Product Code MLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2024
Date Received
September 1, 2023
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

  • 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)
  • K162218 — Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model (November 22, 2016)
  • 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

  • K243654 — DentalJect (May 30, 2025)
  • 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)
  • K172028 — Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium S (October 27, 2017)
  • K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (October 18, 2017)
  • K162218 — Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model (November 22, 2016)