Nidek Model AKC-8000
FDA 510(k)Class II (US FDA 510(k))
by Nidek, Inc.
Identifiers
- 510(k) Number
- K894273 FDA 510(k)
- FDA Product Code
- HQF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nidek Model AKC-8000 is an ophthalmic laser device, specifically classified as a Laser, Ophthalmic under FDA device classification. It is a powered laser surgical instrument intended for use in ophthalmic procedures.
The device is supplied as a reusable system and requires appropriate sterilization between uses. It is regulated as a Class II medical device with FDA 510(k) clearance (K894273) under product code HQF, and is indicated for use in ophthalmic surgical applications as defined by its regulatory classification.
Frequently asked questions
What is the Nidek Model AKC-8000 used for?
The Nidek Model AKC-8000 is a powered laser surgical instrument intended for use in ophthalmic procedures, specifically designed for laser tissue interaction in eye surgery as defined by its FDA classification as a Laser, Ophthalmic device.
Is the Nidek Model AKC-8000 reusable or single-use?
The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate sterilization between each procedure, as stated in the device description.
What regulatory pathway was used for the Nidek Model AKC-8000?
The Nidek Model AKC-8000 received FDA 510(k) clearance (K894273) through a traditional submission process, demonstrating substantial equivalence to a predicate device under product code HQF for Laser, Ophthalmic devices.
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 MODEL AKC-8000 (K894273) — FDA 510 (k) | Innolitics, NIDEK MODEL AKC-8000 510 (k) K894273 - FDA.report, Nidek Model Akc-8000 Ophthalmic Laser Photocoagula (K900890) — Fda 510 ..., NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA 510 (k) K900890 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K894273 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA 510(k) K894273 24 fields · synced Sep 25, 2026