FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
NuEra Tight RF Model OptiStream
K Number: K230755
·
Decision Oct 30, 2023
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
14
Review Days
227
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Basic Information
- Device Name
- NuEra Tight RF Model OptiStream
- K Number
- K230755
- 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
- Bios S.R.L.
- Date Received
- March 17, 2023
- Decision Date
- October 30, 2023
- 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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Other Clearances by Bios S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Dec 30, 2024 | Substantially Equivalent |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Jun 14, 2024 | Substantially Equivalent |
| K223856 | NuEra Tight RF Family | Aug 11, 2023 | Substantially Equivalent |
| K223907 | NuEra Tight RF Model APMD145.M70-US | May 2, 2023 | Substantially Equivalent |
| K210867 | NuEra Tight RF, NuEra Tight RF Plus | Apr 21, 2021 | Substantially Equivalent |
| K201239 | NuEra Tight Family, EMS Model | Dec 31, 2020 | Substantially Equivalent |
| K200359 | NuEra Tight, NuEra Tight EMS | Aug 11, 2020 | Substantially Equivalent |
| K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) | Dec 8, 2016 | Substantially Equivalent |
| K153229 | Superbium | Apr 12, 2016 | Substantially Equivalent |
| K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | Nov 19, 2015 | Substantially Equivalent |