K905141Substantially Equivalent
Centauri
Pfizer Laser Systems, Irvine CA / Traditional, Substantially Equivalent
K905141 is the FDA 510(k) clearance record for CENTAURI, a class II device, cleared for Pfizer Laser Systems on under FDA product code HQF (Laser, Ophthalmic). FDA records list 32 510(k) clearances for Pfizer Laser Systems, from to . As of , FDA records show no recalls naming K905141.
Clearance record
- Decision date
- Received
- (88 days to decision)
- Product code
- HQF Laser, Ophthalmic
- Regulation
- 21 CFR 886.4390
- Device class
- Class II
- Review panel
- Ophthalmic
- Applicant
- Pfizer Laser Systems 3 Morgan, Irvine CA
- Third party review
- No
Clearances, product code HQF
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 1 |
| March 2026 | 0 |
| April 2026 | 1 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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