FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Aimanfun Lumea Comfort, A-2789/A-3588
K Number: K212907
·
Decision Dec 2, 2021
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
73
Applicant Total
5
Review Days
80
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Basic Information
- Device Name
- Aimanfun Lumea Comfort, A-2789/A-3588
- K Number
- K212907
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kam Yuen Plastic Products , Ltd.
- Date Received
- September 13, 2021
- Decision Date
- December 2, 2021
- Product Code
- ONF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Kam Yuen Plastic Products , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K230107 | Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 | Apr 5, 2023 | Substantially Equivalent |
| K213027 | Laser Hair Growth Comb | May 26, 2022 | Substantially Equivalent |
| K213025 | Laser hair growth helmet | May 12, 2022 | Substantially Equivalent |
| K190820 | Aimanfun Lumea Comfort | Oct 2, 2019 | Substantially Equivalent |