FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Deka Bluebeam
K Number: K243683
·
Decision Jun 12, 2025
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
195
Basic Information
- Device Name
- Deka Bluebeam
- K Number
- K243683
- 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
- November 29, 2024
- Decision Date
- June 12, 2025
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
| K250281 | DEKA LOTUS | Feb 26, 2025 | Substantially Equivalent |
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| K234057 | NIRVANA | Apr 10, 2024 | Substantially Equivalent |
| K240537 | SMARTXIDE PRO | Mar 20, 2024 | Substantially Equivalent |
| K240497 | Smartxide Tetra Pro | Mar 12, 2024 | Substantially Equivalent |
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| K232334 | DEKA SIMON | Sep 1, 2023 | Substantially Equivalent |