Home / 510(k) Clearances / K211105

510(k) K211105

Ear-Friendly Mask by Ray Co., Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2021
Date Received
April 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Ray Co., Ltd.

  • K251798 — RCT700 (November 25, 2025)
  • K251109 — SMARTDent (May 21, 2025)
  • K243903 — RCT600 (March 12, 2025)
  • K233625 — RAYDENT SW (May 16, 2024)
  • K232325 — RAYSCAN a-Expert (April 18, 2024)
  • K232287 — RAYSCAN a-Expert3D (August 31, 2023)
  • K230753 — RCT800 (April 11, 2023)
  • K213226 — RCT700 (November 29, 2021)
  • K192737 — RCT800 (October 22, 2019)
  • K190812 — RAYSCAN a-Expert3D (April 24, 2019)

Other clearances for product code FXX

  • K252534 — Surgical Face Mask (Ear mount) (March 3, 2026)
  • K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (February 19, 2026)
  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (January 12, 2026)
  • K252650 — Disposable Medical Face Mask (January 5, 2026)
  • K243342 — KP Protective Face Mask (December 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (December 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with S (September 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)
  • K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); (May 30, 2025)