Model YC-1200/PHOTOCOAGULATOR Ophthalmic Laser

FDA 510(k)

Class II (US FDA 510(k))

510(k) K901481

Identifiers

510(k) Number: K901481 FDA 510(k)
FDA Product Code: GEX FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4810 FDA 510(k)
Regulation Number: 878.4810 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER is a powered laser surgical instrument classified under product code GEX, which corresponds to powered laser surgical instruments across multiple specialties. It is designed for ophthalmic photocoagulation procedures, utilizing laser energy to treat retinal conditions.

This device received FDA 510(k) clearance (K901481) on June 20, 1990, as a substantially equivalent device under traditional review. It is supplied as a reusable, non-sterile instrument intended for use in clinical settings such as ophthalmology offices or surgical centers, with no indication of MRI safety or single-use designation in the provided data.

Frequently asked questions

What is the MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER used for?

It is designed for ophthalmic photocoagulation procedures, using laser energy to treat retinal conditions as a powered laser surgical instrument under product code GEX.

Is the MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER sterile or single-use?

It is supplied as a reusable, non-sterile instrument, intended for repeated use in clinical settings such as ophthalmology offices or surgical centers after appropriate cleaning and sterilization by the user.

What regulatory pathway was used for the MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER?

It received FDA 510(k) clearance (K901481) on June 20, 1990, through a traditional review process as a substantially equivalent device to a legally marketed predicate.

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: FDA Browser - Cleared 510 (K) - MODEL YC-1200/PHOTOCOAGULATOR ..., K901481 FDA 510(k) - MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMI..., PDF K901481 - Model Yc-1200/Photocoagulator Ophthalmic Laser, NIDEK YC-1200 Ophthalmic Yag Laser Photodisruptor Optometry

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K901481	Class II	Active

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Manufacturer

Manufacturer: Nidek, Inc.

Sources (1)

FDA 510(k) K901481 24 fields · synced Sep 24, 2026