FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Ear-Friendly Mask
K Number: K211105
·
Decision May 17, 2021
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
24
Review Days
34
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Basic Information
- Device Name
- Ear-Friendly Mask
- K Number
- K211105
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ray Co., Ltd.
- Date Received
- April 13, 2021
- Decision Date
- May 17, 2021
- Product Code
- FXX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Ray Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260462 | RCT800 | Apr 9, 2026 | Substantially Equivalent |
| K251798 | RCT700 | Nov 25, 2025 | Substantially Equivalent |
| K251109 | SMARTDent | May 21, 2025 | Substantially Equivalent |
| K243903 | RCT600 | Mar 12, 2025 | Substantially Equivalent |
| K233625 | RAYDENT SW | May 16, 2024 | Substantially Equivalent |
| K232325 | RAYSCAN a-Expert | Apr 18, 2024 | Substantially Equivalent |
| K232287 | RAYSCAN a-Expert3D | Aug 31, 2023 | Substantially Equivalent |
| K230753 | RCT800 | Apr 11, 2023 | Substantially Equivalent |
| K213226 | RCT700 | Nov 29, 2021 | Substantially Equivalent |
| K192737 | RCT800 | Oct 22, 2019 | Substantially Equivalent |