FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
DEKA LOTUS
K Number: K233473
·
Decision May 16, 2024
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
73
Applicant Total
15
Review Days
204
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Basic Information
- Device Name
- DEKA LOTUS
- K Number
- K233473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- El.En S.P.A.
- Date Received
- October 25, 2023
- Decision Date
- May 16, 2024
- 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 |
Similar 510(k) Clearances
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Other Clearances by El.En S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K260647 | SPECCHIO | Apr 2, 2026 | Substantially Equivalent |
| K251432 | Olo | Aug 6, 2025 | Substantially Equivalent |
| K243683 | Deka Bluebeam | Jun 12, 2025 | Substantially Equivalent |
| K250281 | DEKA LOTUS | Feb 26, 2025 | Substantially Equivalent |
| K241459 | MOTUS PRO Family | Jun 21, 2024 | Substantially Equivalent |
| K240752 | DEKA TORO | May 16, 2024 | Substantially Equivalent |
| K234057 | NIRVANA | Apr 10, 2024 | Substantially Equivalent |
| K240537 | SMARTXIDE PRO | Mar 20, 2024 | Substantially Equivalent |
| K240497 | Smartxide Tetra Pro | Mar 12, 2024 | Substantially Equivalent |
| K233470 | DEKA LILY | Dec 19, 2023 | Substantially Equivalent |