Identity
- Trade Name
- YAGMASTER ND:YAG OP LASER FDA PMA
- Generic Name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary FDA PMA
Identifiers
- PMA Number
- P850091 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 YAGMaster Nd:YAG Ophthalmic Laser is a neodymium:YAG laser designed for ophthalmic applications excluding posterior capsulotomy and pupillary cutting. It operates as a high-energy laser system intended for precise tissue interaction in eye surgery, leveraging neodymium-doped yttrium aluminum garnet technology to deliver focused laser energy.
This device is supplied as a reusable medical instrument and is regulated under FDA Premarket Approval (PMA) with PMA number P850091. It is classified as a Class III device under the FDA’s regulatory framework, intended for use in controlled clinical settings such as ophthalmology clinics or surgical suites. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What types of ophthalmic procedures is the YAGMaster Nd:YAG Laser specifically designed for, and what procedures does it exclude?
The YAGMaster Nd:YAG Ophthalmic Laser is designed for precise tissue interaction in eye surgeries, leveraging neodymium-doped yttrium aluminum garnet technology. It is explicitly **not** intended for posterior capsulotomy or pupillary cutting. Instead, it is suited for other controlled ophthalmic applications where high-energy laser precision is required, such as certain intraocular procedures.
Is the YAGMaster Nd:YAG Laser a single-use or reusable device, and what does this mean for maintenance and sterilization?
The YAGMaster Nd:YAG Laser is supplied as a **reusable medical instrument**, meaning it is intended for repeated use after proper cleaning, maintenance, and sterilization between procedures. Since it is not classified as sterile upon packaging, facilities must follow established protocols for reprocessing to ensure safety and functionality before each use.
What regulatory pathway does the YAGMaster Nd:YAG Laser follow, and what does this imply for its use in clinical settings?
The YAGMaster Nd:YAG Laser is regulated under the **FDA Premarket Approval (PMA) pathway** with PMA number **P850091**, classifying it as a **Class III device**. This designation indicates it requires rigorous review and approval before commercial distribution, ensuring its safety and effectiveness for controlled clinical use—primarily in specialized ophthalmology clinics or surgical suites where trained personnel can operate high-energy laser systems.
How is the YAGMaster Nd:YAG Laser supplied, and what should buyers consider when integrating it into their facility?
The YAGMaster Nd:YAG Laser is supplied as a **reusable instrument** by Bausch & Lomb, Inc., meaning it requires proper handling, maintenance, and reprocessing between uses. Buyers should account for space for installation, staff training on operation and safety protocols, and compliance with facility protocols for laser safety, including eye protection and environmental controls, given its high-energy output.
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: YAGMASTER ND:YAG OP LASER (P850091) — FDA 510(k) | Innolitics, Bausch-RepFinder, BAUSCH & LOMB Laser - Excimer For Sale or Wanted, Bausch + Lomb Official Home Page, Nd:YAG Laser - an overview | ScienceDirect Topics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P850091 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P850091 24 fields · synced Sep 18, 2026