FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GENESIS 2000
K Number: K944317
·
Decision Oct 11, 1994
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
43
Basic Information
- Device Name
- GENESIS 2000
- K Number
- K944317
- 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
- ION LASER TECHNOLOGY
- Date Received
- August 29, 1994
- Decision Date
- October 11, 1994
- 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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| K944206 | GENESIS 2000 | Oct 11, 1994 | Substantially Equivalent |
| K915656 | CARBON DIOXIDE CO2 LASER | Apr 10, 1992 | Substantially Equivalent |
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