Home / 510(k) Clearances / K093951

510(k) K093951

OUCHLESS MODEL PN10114 by Occam Design — Product Code MLY

K093951 is an FDA 510(k) premarket notification submitted by Occam Design for the device "OUCHLESS MODEL PN10114". The FDA issued a decision of Substantially Equivalent on June 15, 2010. The device falls under product code MLY (Vapocoolant Device), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2010
Date Received
December 23, 2009
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 for product code MLY

  • 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)
  • K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (October 18, 2017)

FDA data resources