FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINON
K Number: K040433
·
Decision May 19, 2004
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
8
Review Days
90
Basic Information
- Device Name
- SINON
- K Number
- K040433
- 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
- WAVELIGHT LASER TECHNOLOGIE AG
- Date Received
- February 19, 2004
- Decision Date
- May 19, 2004
- 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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Other Clearances by WAVELIGHT LASER TECHNOLOGIE AG
| K Number | Device Name | ||
|---|---|---|---|
| K053604 | WAVELIGHT IDAS | Feb 22, 2006 | Substantially Equivalent |
| K052806 | BURANE | Oct 17, 2005 | Substantially Equivalent |
| K051399 | WAVELIGHT AURIGA | Jun 30, 2005 | Substantially Equivalent |
| K050317 | BURANE XL | Feb 24, 2005 | Substantially Equivalent |
| K050218 | WAVELIGHT SINON | Feb 15, 2005 | Substantially Equivalent |
| K042474 | ARION | Sep 29, 2004 | Substantially Equivalent |
| K040384 | MYDON C | May 14, 2004 | Substantially Equivalent |