FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Forma System, Forma Light System
K Number: K160195
·
Decision Apr 15, 2016
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
73
Applicant Total
4
Review Days
79
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Basic Information
- Device Name
- Forma System, Forma Light System
- K Number
- K160195
- 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
- Formatk Systems , Ltd.
- Date Received
- January 27, 2016
- Decision Date
- April 15, 2016
- 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 |
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