FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEKA SMARTXIDE LASER SYSTEM
K Number: K133895
·
Decision Sep 5, 2014
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
15
Review Days
259
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Basic Information
- Device Name
- DEKA SMARTXIDE LASER SYSTEM
- K Number
- K133895
- 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
- December 20, 2013
- Decision Date
- September 5, 2014
- 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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|---|---|---|---|
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| 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 |
| K233473 | DEKA LOTUS | May 16, 2024 | Substantially Equivalent |
| K234057 | NIRVANA | Apr 10, 2024 | Substantially Equivalent |
| K240537 | SMARTXIDE PRO | Mar 20, 2024 | Substantially Equivalent |
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