Identity
- Trade Name
- HORIZON(TM) YAG LASER MODEL 2000 FDA PMA
- Generic Name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary FDA PMA
Identifiers
- PMA Number
- P850001 FDA PMA
- FDA Product Code
- LOI FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S001 FDA PMA
The Horizon Yag Laser Model 2000 is an ophthalmic neodymium:Yag laser device intended for uses other than posterior capsulotomy and cutting pupillary. It is manufactured by CooperVision Inc. and classified as a Class III medical device under FDA PMA authorization.
This device is supplied as a reusable laser system for use in ophthalmic clinical settings. It requires appropriate safety controls and is not designated as sterile, single-use, or MRI safe based on the provided data. Storage and handling should follow manufacturer guidelines for ophthalmic laser equipment.
Frequently asked questions
What is the Horizon Yag Laser Model 2000 used for?
The Horizon Yag Laser Model 2000 is an ophthalmic neodymium:Yag laser intended for uses other than posterior capsulotomy and cutting pupillary, as defined in its generic name and device classification.
Who manufactures the Horizon Yag Laser Model 2000?
The Horizon Yag Laser Model 2000 is manufactured by CooperVision Inc., as stated in the applicant and manufacturer fields of the device data.
Is the Horizon Yag Laser Model 2000 a single-use device?
The device data does not specify that the Horizon Yag Laser Model 2000 is single-use; it is described as a laser system, which implies reusable operation in a clinical setting, but no explicit statement on reusability or single-use status is provided.
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 | P850001 | Class III | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA PMA P850001 23 fields · synced Sep 18, 2026