Nidek Multicolor Laser Photocoagulator
FDA 510(k) K110228 · Nidek Incorporated
510(k) numberK110228
Submission
- Device name
- Nidek Multicolor Laser Photocoagulator
- Applicant
- Nidek Incorporated
Sunnyvale, CA, US - Received
- January 26, 2011
- Decision date
- February 23, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQB – Photocoagulator And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4690
- Specialty
- Ophthalmic
Other 510(k)s with product code HQB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical…HQB · Traditional | Vortex Surgical, Inc. | 11/03/2022SE |
| K191846 | MAXReach Laser ProbeHQB · Traditional | Vortex Surgical, Inc. | 12/23/2019SE |
| K182646 | Vitreq disposable laser probes, light fibers and ChandelierHQB · Traditional | VitreQ BV | 05/01/2019SE |
| K132614 | Peregrine Curved Illuminating Laser ProbeHQB · Special | Peregrine Surgical , Ltd. | 11/14/2013SE |
| K122997 | 23GA Curved Illuminating Laser ProbeHQB · Special | Peregrine Surgical , Ltd. | 06/26/2013SE |
| K122905 | Peregrine 23GA Curved Laser ProbeHQB · Special | Peregrine Surgical , Ltd. | 04/30/2013SE |
| K113857 | Synergetics Directional Endoocular Laser ProbeHQB · Traditional | Synergetics, Inc. | 04/23/2012SE |
| K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…HQB · Traditional | Alcon Research, Ltd. | 10/17/2011SE |
| K111493 | Nidek Multicolor Scan Laser Photocoagulator MC-500 VixiHQB · Traditional | Nidek Co., Ltd. | 07/27/2011SE |
| K964380 | LC-250 Infrared Light CoagulatorHQB · Traditional | Nk-Optik America | 01/22/1997SE |
More from Nk-Optik America
| 510(k) | Device | Decision |
|---|---|---|
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…OBO · Traditional | 03/30/2023SE |
| 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 Multicolor Laser Photocoagulator cleared by the FDA?
Nidek Multicolor Laser Photocoagulator (K110228) received a 510(k) decision of Substantially Equivalent on February 23, 2011, 28 days after the submission was received.
What is the product code of K110228?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.