FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Deka Tiac II
K Number: K211091
·
Decision Oct 15, 2021
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
27
Review Days
186
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Basic Information
- Device Name
- Deka Tiac II
- K Number
- K211091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- El.En Electronic Engineering Spa
- Date Received
- April 12, 2021
- Decision Date
- October 15, 2021
- Product Code
- PBX
- 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 |
|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| 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 |