FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTAURI YAG LASER SYST, GASTROENTEROLOGY
K Number: K904628
·
Decision Jan 7, 1991
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
32
Review Days
90
Basic Information
- Device Name
- CENTAURI YAG LASER SYST, GASTROENTEROLOGY
- K Number
- K904628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- PFIZER LASER SYSTEMS
- Date Received
- October 9, 1990
- Decision Date
- January 7, 1991
- 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 PFIZER LASER SYSTEMS
| K Number | Device Name | ||
|---|---|---|---|
| K911288 | ORION | Nov 16, 1993 | Substantially Equivalent |
| K910826 | ORION YAG LASER SYSTEM OPHTHALMOLOGY | Nov 16, 1993 | Substantially Equivalent |
| K910825 | ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC. | Feb 26, 1993 | Substantially Equivalent |
| K912067 | POLARIS, GYNECOLOGY INDICATIONS | Jun 16, 1992 | Substantially Equivalent |
| K910152 | ORION | Apr 15, 1992 | Substantially Equivalent |
| K912813 | SIRIUS | Dec 31, 1991 | Substantially Equivalent |
| K911926 | POLARIS, OPHTHALMOLOGY | Nov 7, 1991 | Substantially Equivalent |
| K912063 | POLARIS, ORAL INDICATION | Oct 16, 1991 | Substantially Equivalent |
| K910341 | POLARIS | Oct 11, 1991 | Substantially Equivalent |
| K911925 | POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GU | Oct 11, 1991 | Substantially Equivalent |