Nidek AC-2000 Laser System
FDA 510(k) K860011 · Nidek, Inc.
510(k) numberK860011
Submission
- Device name
- Nidek AC-2000 Laser System
- Applicant
- Nidek, Inc.
Palo Alto, CA, US - Received
- January 3, 1986
- Decision date
- February 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQB – Photocoagulator And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4690
- Specialty
- Ophthalmic
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More from Nidek Incorporated
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| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…OBO · Traditional | 03/30/2023SE |
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| 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 AC-2000 Laser System cleared by the FDA?
Nidek AC-2000 Laser System (K860011) received a 510(k) decision of Substantially Equivalent on February 7, 1986, 35 days after the submission was received.
What is the product code of K860011?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.