FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIASCOPE II
K Number: K023729
·
Decision Feb 3, 2003
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
9
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- SIASCOPE II
- K Number
- K023729
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Astron Clinica Limited
- Date Received
- November 6, 2002
- Decision Date
- February 3, 2003
- Product Code
- PSN
- 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 |
|---|---|---|---|
| PSN | Light Based Imaging | FDA class 2 | General, Plastic Surgery |
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