FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
MINISILK FT
K Number: K082040
·
Decision Aug 27, 2009
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
73
Applicant Total
27
Review Days
405
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MINISILK FT
- K Number
- K082040
- 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 18, 2008
- Decision Date
- August 27, 2009
- Product Code
- ONF
- 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 |
|---|---|---|---|
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ONF), ordered by most recent decision date.
Intense Pulsed Light Therapy Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Intense Pulsed Light Therapy Device (MMABM-1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDILIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPL Treatment Device (MDSQMC-01)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEKA LOTUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Intense Pulsed Light Treatment System (LK-PT)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K212270 | DEKA LipoAI | Oct 21, 2021 | 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 |