FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
W.O.M. LASER U100
K Number: K011175
·
Decision Nov 1, 2001
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
17
Review Days
198
Basic Information
- Device Name
- W.O.M. LASER U100
- K Number
- K011175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- W.O.M. WORLD OF MEDICINE, GMBH
- Date Received
- April 17, 2001
- Decision Date
- November 1, 2001
- 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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| K983910 | ARTHRO-SURGIMAT-1500 | Nov 25, 1998 | Substantially Equivalent |
| K981859 | SURGIFLATOR-20 ECU | Jun 26, 1998 | Substantially Equivalent |
| K973432 | SURGIFLATOR-30 | Dec 9, 1997 | Substantially Equivalent |
| K955791 | SURGIFLATOR-20 PIM | Dec 17, 1996 | Substantially Equivalent |
| K962114 | ARTHRO-SURGIMAT | Aug 22, 1996 | Substantially Equivalent |
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