FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OASYS SURGICAL LIGHT CONTROLLER
K Number: K112133
·
Decision Mar 1, 2012
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
25
Applicant Total
1
Review Days
219
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Basic Information
- Device Name
- OASYS SURGICAL LIGHT CONTROLLER
- K Number
- K112133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oasys Healthcare
- Date Received
- July 26, 2011
- Decision Date
- March 1, 2012
- Product Code
- FTA
- 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 |
|---|---|---|---|
| FTA | Light, Surgical, Accessories | FDA class 2 | General, Plastic Surgery |
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