FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTAURI
K Number: K905141
·
Decision Feb 11, 1991
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
32
Review Days
88
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Basic Information
- Device Name
- CENTAURI
- K Number
- K905141
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Pfizer Laser Systems
- Date Received
- November 15, 1990
- Decision Date
- February 11, 1991
- Product Code
- HQF
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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Other Clearances by Pfizer Laser Systems
| K Number | Device Name | ||
|---|---|---|---|
| K910826 | ORION YAG LASER SYSTEM OPHTHALMOLOGY | Nov 16, 1993 | Substantially Equivalent |
| K911288 | ORION | 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 |