Nidek Inc. Models YC-2000 & 3000 Ophthalmic Lasers
FDA 510(k) K892204 · Nidek, Inc.
510(k) numberK892204
Submission
- Device name
- Nidek Inc. Models YC-2000 & 3000 Ophthalmic Lasers
- Applicant
- Nidek, Inc.
El Toro, CA, US - Received
- April 3, 1989
- Decision date
- June 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LXS – Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4392
- Specialty
- Ophthalmic
Other 510(k)s with product code LXS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023045 | Microrupter VLXS · Traditional | Meridian AG | 09/26/2002SE |
| K901605 | Phoenix Laser Systems Ophthalmic Surgical Worksta.LXS · Traditional | Phoenix Laser Systems, Inc. | 12/13/1990SE |
| K895864 | Microruptor III Syst, Q-Switched Nd:Yag Laser CompLXS · Traditional | Lasag AG | 12/29/1989SE |
| K893987 | Nidek Model YC-1200LXS · Traditional | Nidek, Inc. | 08/18/1989SE |
| K892058 | Isl QC 2000LXS · Traditional | Intelligent Surgical Lasers, Inc. | 06/15/1989SE |
More from Intelligent Surgical Lasers, Inc.
| 510(k) | Device | Decision |
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| K203130 | Ophthalmic Yag Laser System YC-200HQF · Traditional | 12/07/2020SE |
| K192045 | Ophthalmic Yag Laser System YC-200HQF · Traditional | 11/15/2019SE |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type SHKI · Traditional | 04/01/2019SE |
| K181345 | Image Filing Software NAVIS-EXNFJ · Traditional | 07/19/2018SE |
| K173980 | Specular Microscope CEM-530NQE · Traditional | 03/14/2018SE |
| K170302 | Yellow Laser Photocoagulator YLC-500HQF · Traditional | 06/23/2017SE |
| K163564 | Slit Lamp SL-2000HJO · Traditional | 05/19/2017SE |
| K152729 | Microperimeter MP-3HKI · Traditional | 06/06/2016SE |
| K152603 | Green Laser Photocoagulator GYC-500HQF · Traditional | 05/02/2016SE |
Questions and answers
When was Nidek Inc. Models YC-2000 & 3000 Ophthalmic Lasers cleared by the FDA?
Nidek Inc. Models YC-2000 & 3000 Ophthalmic Lasers (K892204) received a 510(k) decision of Substantially Equivalent on June 22, 1989, 80 days after the submission was received.
What is the product code of K892204?
The FDA product code is LXS – Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla, a Class II (moderate risk) device regulated under 21 CFR 886.4392.