FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CLAROS DENTAL LASER SYSTEM
K Number: K063152
·
Decision Mar 7, 2007
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
2
Review Days
142
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Basic Information
- Device Name
- CLAROS DENTAL LASER SYSTEM
- K Number
- K063152
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elexxion AG
- Date Received
- October 16, 2006
- Decision Date
- March 7, 2007
- 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 Elexxion AG
| K Number | Device Name | ||
|---|---|---|---|
| K081652 | CLAROS NANO DENTAL LASER SYSTEM | Aug 28, 2008 | Substantially Equivalent |