NIDEK MULTICOLOR LASER PHOTOCOAGULATOR— 510(k) K110228
Substantially EquivalentNidek Incorporated
FDA 510(k) clearance K110228 for NIDEK MULTICOLOR LASER PHOTOCOAGULATOR, Substantially Equivalent on 2011-02-23. Applicant: Nidek Incorporated. Device class: 2.
Clearance details
- Applicant
- Nidek Incorporated
- Product code
- Code HQB
- Device class
- Class 2
- Regulation
- 21 CFR 886.4690
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Recent devices under product code HQB
view all- K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
- K191846 — MAXReach Laser Probe
- K182646 — Vitreq disposable laser probes, light fibers and Chandelier
- K132614 — PEREGRINE CURVED ILLUMINATING LASER PROBE
- K122997 — 23GA CURVED ILLUMINATING LASER PROBE
Adverse events under product code HQB
product code HQB- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110228
K-number listed on FDA's recall record- Z-2132-2014 — MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
- Z-0222-2015 — MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
- Z-0224-2015 — Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
- Z-1127-2015 — MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110228.
Data sourced from openFDA. This site is unofficial and independent of the FDA.