O.M.S. Ultra-Phaco
FDA 510(k) K844373 · Optical Micro Systems, Inc.
510(k) numberK844373
Submission
- Device name
- O.M.S. Ultra-Phaco
- Applicant
- Optical Micro Systems, Inc.
Danvers, MA, US - Received
- November 13, 1984
- Decision date
- December 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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More from Alcon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950218 | Oms Slimline Phaco HandpieceHQC · Traditional | 07/17/1995SE |
| K946054 | DiplomaxHQC · Traditional | 07/11/1995SE |
| K935223 | Ophthalmic Surgical SystemHQC · Traditional | 03/14/1994SE |
| K935226 | I/V PoleKYG · Traditional | 02/16/1994SE |
| K935003 | Electric I/V Pole or EIVP2KYG · Traditional | 01/25/1994SE |
| K870068 | Aspiration Reversal Control (Arc) ModuleHQE · Traditional | 02/12/1987SE |
| K844448 | Oms/Gonvers Retinal PerforatorHNM · Traditional | 08/21/1985SE |
| K844895 | Oms Silicone Oil InjectorLWL · Traditional | 06/24/1985SE |
| K844467 | Oms Cryo · Traditional | 02/22/1985SE |
| K844715 | Visc-X Vitreous Aspirating & Cutting Instrument SyHQE · Traditional | 01/22/1985SE |
Questions and answers
When was O.M.S. Ultra-Phaco cleared by the FDA?
O.M.S. Ultra-Phaco (K844373) received a 510(k) decision of Substantially Equivalent on December 19, 1985, 401 days after the submission was received.
What is the product code of K844373?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.