Nidek AC-2000 Laser System
FDA 510(k)Class II (US FDA 510(k))
by Nidek, Inc.
Identifiers
- 510(k) Number
- K860011 FDA 510(k)
- FDA Product Code
- HQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4690 FDA 510(k)
- Regulation Number
- 886.4690 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nidek AC-2000 Laser System is a photocoagulator designed for ophthalmic use, delivering laser energy to treat retinal conditions. It employs argon laser technology to perform precise photocoagulation, targeting vascular abnormalities, diabetic retinopathy, or macular edema under controlled clinical settings. Its classification as a Class II device reflects its moderate risk and regulatory oversight requirements.
This system is intended for use in ophthalmic clinics and hospitals, where it is operated by trained professionals. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure safety and efficacy. The AC-2000 adheres to FDA regulatory standards, having received a 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What clinical conditions is the Nidek AC-2000 Laser System primarily used to treat in ophthalmology?
The Nidek AC-2000 Laser System is designed for photocoagulation procedures targeting retinal conditions such as vascular abnormalities, diabetic retinopathy, and macular edema. Its argon laser technology allows precise delivery of energy to treat these conditions under controlled clinical settings.
Is the Nidek AC-2000 Laser System intended for single-use or reusable applications, and what maintenance is required?
The Nidek AC-2000 Laser System is supplied as a reusable medical device, meaning it is meant for repeated use in ophthalmic clinics and hospitals. Since it is reusable, proper maintenance and calibration are essential to ensure safety, efficacy, and compliance with regulatory standards.
How was the regulatory pathway for the Nidek AC-2000 Laser System determined, and what does the decision code SESE indicate?
The Nidek AC-2000 Laser System underwent FDA review through the traditional 510(k) pathway, which compares it to a legally marketed predicate device. The decision code SESE (Substantially Equivalent) confirms that the FDA determined it to be substantially equivalent in safety and performance to an existing device, meeting regulatory requirements for Class II devices.
What types of facilities are authorized to use the Nidek AC-2000 Laser System, and who operates it?
The Nidek AC-2000 Laser System is intended for use in ophthalmic clinics and hospitals, where it must be operated by trained professionals familiar with laser photocoagulation techniques. Its design and regulatory classification reflect its use in controlled clinical settings.
Are there any specific storage or handling requirements mentioned for the Nidek AC-2000 Laser System?
The provided data does not explicitly detail storage or handling requirements for the Nidek AC-2000 Laser System. However, as a reusable medical device, it should be stored in a clean, controlled environment to prevent contamination and damage, following manufacturer guidelines for maintenance and calibration.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NIDEK AC-2000 LASER SYSTEM (K860011) — FDA 510(k) | Innolitics, Nidek Ac-2000 Laser System 510 (k) FDA Premarket Notification K860011 ..., PDF K860011 NIDEK AC-2000 LASER SYSTEM - 510kdatabase.net, NIDEK AC-2000 Argon Laser Photocoagulator Zeiss, NIDEK Ophthalmic Laser For Sale and Wanted - dotmed.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K860011 | Class II | Active |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA 510(k) K860011 24 fields · synced Sep 20, 2026