Micro Yag Nd:Yag Laser System
PMA P850063
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP850063 | Date17 Jun 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- PMA Number
- FDA Product Code
- LOI
- Device Class
- Class III
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Overview
AI-generated summary, 18 Sep 2026
The Micro Yag Nd:Yag Laser System is an ophthalmic laser device designed for medical applications. It functions as a neodymium:Yag laser system specifically indicated for ophthalmic procedures other than posterior capsulotomy and cutting pupillary membranes.
This device is manufactured by Sorin Group USA, Inc. and is authorized for use under FDA PMA P850063. It is classified as a class 3 medical device within the ophthalmic specialty category.
Other devices from Sorin Group USA, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary use of the Micro Yag Nd:Yag Laser System?
This device is an ophthalmic laser intended for specific eye procedures, excluding posterior capsulotomy and the cutting of pupillary membranes.
Who is the manufacturer of this laser system?
The Micro Yag Nd:Yag Laser System is manufactured by Sorin Group USA, Inc., based in Arvada, Colorado.
Is this device authorized for clinical use?
Yes, the device has received FDA PMA authorization under reference number P850063, confirming it has met the necessary regulatory requirements for its intended ophthalmic applications.