American Medical Optics I/A Kit- Irrig
FDA 510(k) K842197 · American Medical Optics
510(k) numberK842197
Submission
- Device name
- American Medical Optics I/A Kit- Irrig
- Applicant
- American Medical Optics
Walker, MI, US - Received
- June 4, 1984
- Decision date
- October 1, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
Other 510(k)s with product code HQE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212763 | UniVit HE, UniVit UHSHQE · Traditional | Visioncare Devices, LLC | 08/10/2022SE |
| K170183 | Cetus system, Cetus probeHQE · Traditional | A.R.C Laser GmbH | 09/27/2017SE |
| K153168 | Bi-Blade Vitrectomy CutterHQE · Special | Medical Instrument Development Laboratories | 04/29/2016SE |
| K141065 | Constellation Vision SystemHQE · Traditional | Alcon Research, Ltd. | 08/22/2014SE |
| K121675 | VersavitHQE · Traditional | Synergetics, Inc. | 06/21/2012SE |
| K120170 | Procare Plus Vitrectomy SystemHQE · Traditional | Visioncare Devices, Inc. | 05/30/2012SE |
| K102222 | Ultimate Vit Enhamcer (Uve)HQE · Traditional | Medical Instrument Development Laboratories, Inc. | 04/08/2011SE |
| K033390 | Colibri Disposable Vitrectomy CutterHQE · Traditional | Microworld Medical Instruments, Inc. | 11/04/2003SE |
| K030948 | Vmate Model VMM1000HQE · Traditional | Howard Instruments, Inc. | 06/17/2003SE |
| K023939 | Velocity AdvantageHQE · Traditional | Visioncare Devices, Inc. | 04/17/2003SE |
More from Visioncare Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K860001 | Barraquer-Krumeich Refractive SetHNO · Traditional | 02/04/1986SE |
| K851264 | Amer. Medical Optics Monocular Indirect OphthalmasHLI · Traditional | 05/01/1985SE |
| K851263 | Amer. Medical Optic Monocular Direct OphthalmascopHLI · Traditional | 05/01/1985SE |
| K851262 | Amer. Medical Optical Binocular Indirect OphthalmaHLI · Traditional | 04/30/1985SE |
| K844150 | Medical Optics Phacoemulsification KitHQC · Traditional | 12/11/1984SE |
| K843966 | Argon/Krypton Laser Photocoagulator SysHQB · Traditional | 11/08/1984SE |
| K843965 | Argon Laser Photocoagulator SysHQF · Traditional | 11/06/1984SE |
| K842504 | Amer. Medical Optics Digital Kerato-HQL · Traditional | 10/01/1984SE |
| K842127 | American Medical Optics Imaging SysIYO · Traditional | 09/07/1984SE |
| K842251 | Ameri. Medical Optics Argon Laser PhotoHQF · Traditional | 08/15/1984SE |
Questions and answers
When was American Medical Optics I/A Kit- Irrig cleared by the FDA?
American Medical Optics I/A Kit- Irrig (K842197) received a 510(k) decision of Substantially Equivalent on October 1, 1984, 119 days after the submission was received.
What is the product code of K842197?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.