Nd:YAG Posterior Capsulotomy Model 100
FDA PMAClass III (US FDA PMA)
by Nidek, Inc.
Identity
- Trade Name
- ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 FDA PMA
- Generic Name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary FDA PMA
Identifiers
- PMA Number
- P830062 FDA PMA
- FDA Product Code
- LOI FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APWD FDA PMA
The Nd:YAG Posterior Capsulotomy Model 100 is a neodymium-doped yttrium aluminium garnet (Nd:YAG) laser designed specifically for ophthalmic use. It is intended for performing posterior capsulotomy, a procedure to open a clouded lens capsule following cataract surgery, restoring clear vision by removing opacification without removing the intraocular lens.
This device is supplied as a Class III medical laser, regulated under an FDA Premarket Approval (PMA) application (P830062). It is used in clinical settings such as ophthalmology clinics and hospitals, typically in sterile or semi-sterile environments. The Model 100 is a reusable medical device, requiring proper maintenance and calibration as per manufacturer guidelines, and is not intended for MRI use.
Frequently asked questions
What clinical procedure is the Nd:YAG Posterior Capsulotomy Model 100 specifically designed for, and how does it differ from other lasers in its category?
The Nd:YAG Posterior Capsulotomy Model 100 is designed exclusively for performing posterior capsulotomy, a procedure to clear opacification of the lens capsule after cataract surgery without removing the intraocular lens. Unlike other lasers in its category, such as those used for pupillary cutting or general ophthalmic tissue ablation, this device is tailored to restore clear vision by creating a precise opening in the clouded capsule, ensuring minimal disruption to the existing intraocular lens.
Is the Nd:YAG Posterior Capsulotomy Model 100 a single-use or reusable device, and what maintenance is required?
The Nd:YAG Posterior Capsulotomy Model 100 is a reusable medical device. Since it is classified as a Class III laser, it requires proper maintenance, calibration, and adherence to manufacturer guidelines to ensure safety and performance. Regular servicing is essential to maintain accuracy and reliability in clinical settings like ophthalmology clinics or hospitals.
What type of regulatory approval does this device hold, and how does that affect its use in clinical settings?
The Nd:YAG Posterior Capsulotomy Model 100 holds FDA Premarket Approval (PMA) under application number P830062, confirming it meets stringent regulatory standards for Class III medical lasers. This approval ensures its use is governed by strict clinical protocols, typically in sterile or semi-sterile environments like ophthalmology clinics or hospitals, where trained professionals perform procedures under controlled conditions.
Can this device be used in environments where MRI machines are present, and why?
No, the Nd:YAG Posterior Capsulotomy Model 100 is explicitly **not** intended for MRI use. The device’s design and materials are not compatible with magnetic resonance imaging environments, which require specialized equipment that avoids interference with magnetic fields. Using it near MRI machines could pose risks to both the device and the imaging process.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P830062 | Class III | Active |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA PMA P830062 24 fields · synced Sep 18, 2026