Centauri
FDA 510(k) K905141 · Pfizer Laser Systems
510(k) numberK905141
Submission
- Device name
- Centauri
- Applicant
- Pfizer Laser Systems
Irvine, CA, US - Received
- November 15, 1990
- Decision date
- February 11, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQF – Laser, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
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| K911288 | OrionGEX · Traditional | 11/16/1993SE |
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| K910825 | Orion Yag Laser System Ear, Nose, & Throat Applic.GEX · Traditional | 02/26/1993SE |
| K912067 | Polaris, Gynecology IndicationsGEX · Traditional | 06/16/1992SE |
| K910152 | OrionGEX · Traditional | 04/15/1992SE |
| K912813 | SiriusGEX · Traditional | 12/31/1991SE |
| K911926 | Polaris, OphthalmologyGEX · Traditional | 11/07/1991SE |
| K912063 | Polaris, Oral IndicationGEX · Traditional | 10/16/1991SE |
| K911925 | Polaris, Gastroenterology/Urology/Pulmonary, Gi/GuGEX · Traditional | 10/11/1991SE |
| K910341 | PolarisGEX · Traditional | 10/11/1991SE |
Questions and answers
When was Centauri cleared by the FDA?
Centauri (K905141) received a 510(k) decision of Substantially Equivalent on February 11, 1991, 88 days after the submission was received.
What is the product code of K905141?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.