FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECLIPSE 2000
K Number: K961560
·
Decision Jan 27, 1997
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
20
Review Days
291
Basic Information
- Device Name
- ECLIPSE 2000
- K Number
- K961560
- 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
- CARDIOGENES
- Date Received
- April 11, 1996
- Decision Date
- January 27, 1997
- 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 CARDIOGENES
| K Number | Device Name | ||
|---|---|---|---|
| K955006 | ECLIPSE 2100 | Jan 17, 1996 | Substantially Equivalent |
| K952755 | POWERSCULPTOR PROBES | Sep 14, 1995 | Substantially Equivalent |
| K953658 | CORSSFIRE PLUS | Aug 21, 1995 | Substantially Equivalent |
| K953424 | ECLIPSE 3200 | Aug 11, 1995 | Substantially Equivalent |
| K945126 | ECLIPSE 3200 | Jan 18, 1995 | Substantially Equivalent |
| K944758 | SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT | Dec 27, 1994 | Unknown |
| K944153 | ECLIPSE 3200 | Nov 9, 1994 | Substantially Equivalent |
| K944151 | OPTICAL FIBER FOR ENT APPLICATIONS | Nov 1, 1994 | Substantially Equivalent |
| K943171 | CROSSFIRE(TM) (705-10650) | Sep 20, 1994 | Substantially Equivalent |
| K943311 | ECLIPSE 3200 | Jul 22, 1994 | Substantially Equivalent |