Mentor Meridian Phacoemulsification System
FDA 510(k) K955245 · Mentor O & O, Inc.
510(k) numberK955245
Submission
- Device name
- Mentor Meridian Phacoemulsification System
- Applicant
- Mentor O & O, Inc.
Norwell, MA, US - Received
- November 15, 1995
- Decision date
- February 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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| K934320 | Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion AspirationHQR · Traditional | 02/16/1994SE |
| K912904 | Mentor Odyssey Phacoemulsification SystemHQC · Traditional | 06/11/1992SE |
| K915340 | Mentor Horizon Low Vision MagnifierHJG · Traditional | 03/30/1992SE |
| K910637 | Mentor(R) Sur-E-Trol(R)FRN · Traditional | 05/13/1991SE |
| K911160 | Mentor(R) Wet-Field(R) II Ac Coagulator, 22-1305GEI · Traditional | 05/02/1991SE |
| K903878 | Mentor(R) Durastat(Tm) Autoclav Bipolar HemostatHQQ · Traditional | 11/05/1990SE |
| K895010 | Mentor Spectacle Binocular Indirect OphthalmoscopeHLI · Traditional | 09/11/1989SE |
| K890622 | Surg-E-Trol System I and System IIHQE · Traditional | 05/04/1989SE |
| K890595 | Mentor Anterior Segment VitrectorHKP · Traditional | 04/17/1989SE |
| K881001 | Mentor Wet-Field*Ii CoagulatorHQQ · Traditional | 05/13/1988SE |
Questions and answers
When was Mentor Meridian Phacoemulsification System cleared by the FDA?
Mentor Meridian Phacoemulsification System (K955245) received a 510(k) decision of Substantially Equivalent on February 12, 1996, 89 days after the submission was received.
What is the product code of K955245?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.