FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBERLAS 100 MEDICAL SYSTEM
K Number: K833499
·
Decision Apr 2, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
59
Applicant Total
1
Review Days
180
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Basic Information
- Device Name
- FIBERLAS 100 MEDICAL SYSTEM
- K Number
- K833499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Fiberlase U.S.A.
- Date Received
- October 5, 1983
- Decision Date
- April 2, 1984
- Product Code
- LNK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LNK | Laser For Gastro-Urology Use | FDA class 2 | General, Plastic Surgery |
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