FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRI*STAR
K Number: K930711
·
Decision Jul 30, 1993
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
19
Applicant Total
1
Review Days
169
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Basic Information
- Device Name
- TRI*STAR
- K Number
- K930711
- 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
- Light Technology Systems
- Date Received
- February 11, 1993
- Decision Date
- July 30, 1993
- Product Code
- FSS
- 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 |
|---|---|---|---|
| FSS | Light, Surgical, Floor Standing | FDA class 2 | General, Plastic Surgery |
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