FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASER-SHIELD II(TM)
K Number: K901016
·
Decision Aug 29, 1990
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
82
Review Days
177
Basic Information
- Device Name
- LASER-SHIELD II(TM)
- K Number
- K901016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- XOMED, INC.
- Date Received
- March 5, 1990
- Decision Date
- August 29, 1990
- 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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|---|---|---|---|
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| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Feb 8, 2000 | Substantially Equivalent |
| K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT | Jan 21, 2000 | Substantially Equivalent |
| K993582 | MODIFICATION TO LASER-SHIELD II | Jan 20, 2000 | Substantially Equivalent |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Dec 21, 1999 | Substantially Equivalent |