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510(k) K260870

Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) by Gebauer Company — Product Code MLY

K260870 is an FDA 510(k) premarket notification submitted by Gebauer Company for the device "Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)". The FDA issued a decision of Substantially Equivalent on August 27, 2026. The device falls under product code MLY (Vapocoolant Device), a Class U device. Gebauer Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2026
Date Received
March 17, 2026
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 Gebauer Company

  • K190161 — Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chlo (May 7, 2019)
  • K172028 — Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium S (October 27, 2017)
  • K032671 — GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPR (March 17, 2004)
  • K031036 — GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN (July 10, 2003)
  • K021726 — GEBAUER'S INSTANT ICE (December 12, 2002)
  • K981693 — SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MO (August 6, 2001)
  • K002596 — GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 (February 15, 2001)
  • K001624 — GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 (January 25, 2001)
  • K991514 — GEBAUER'S CHLORIDE FINE NOZZE (July 16, 1999)
  • K930915 — FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE (September 29, 1994)

Other clearances for product code MLY

  • K261684 — FreezeSpray TA (September 5, 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)
  • K172028 — Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium S (October 27, 2017)

FDA data resources