FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
DEKA LipoAI
K Number: K212270
·
Decision Oct 21, 2021
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
27
Review Days
93
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Basic Information
- Device Name
- DEKA LipoAI
- K Number
- K212270
- 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 Electronic Engineering Spa
- Date Received
- July 20, 2021
- Decision Date
- October 21, 2021
- 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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Other Clearances by El.En Electronic Engineering Spa
| K Number | Device Name | ||
|---|---|---|---|
| K222221 | DEKA HELIX | Jan 4, 2023 | Substantially Equivalent |
| K213658 | DEKA SMARTPERIO | Mar 11, 2022 | Substantially Equivalent |
| K211091 | Deka Tiac II | Oct 15, 2021 | Substantially Equivalent |
| K211362 | SCAR 3 | Aug 25, 2021 | Substantially Equivalent |
| K203396 | DEKA SMARTPERIO | Aug 23, 2021 | Substantially Equivalent |
| K211821 | DEKA Motus AZ | Jul 6, 2021 | Substantially Equivalent |
| K202258 | ERISE Laser handpiece | Apr 26, 2021 | Substantially Equivalent |
| K202079 | Physiq | Nov 25, 2020 | Substantially Equivalent |
| K192539 | Deka Luxea | Dec 16, 2019 | Substantially Equivalent |
| K181867 | Deka Smartxide2 Trio | Oct 2, 2018 | Substantially Equivalent |