FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOSYAG MEDICAL SYSTEM
K Number: K080374
·
Decision May 15, 2008
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
5
Review Days
93
Basic Information
- Device Name
- BIOSYAG MEDICAL SYSTEM
- K Number
- K080374
- 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
- BIOS S.R.L.
- Date Received
- February 12, 2008
- Decision Date
- May 15, 2008
- 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 BIOS S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) | Dec 8, 2016 | Substantially Equivalent |
| K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | Nov 19, 2015 | Substantially Equivalent |
| K072344 | APL MEDICAL SYSTEM | Dec 3, 2007 | Substantially Equivalent |
| K043521 | BIOSYAG 50 MED | Mar 24, 2005 | Substantially Equivalent |