Neodymium: Yag Ophthalmic Laser System 9900
PMA P830054
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830054 | Date16 Jan 1985 | 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- Withdrawn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 Neodymium: Yag Ophthalmic Laser System 9900 is an ophthalmic laser device manufactured by Coherent Medical Division. It is designed for ophthalmic surgical procedures excluding posterior capsulotomy and pupillary cutting.
This device is identified under PMA number P830054 and received FDA PMA authorization in 1985. It is classified as a class 3 medical device within the ophthalmic specialty category.
Other devices from Coherent Medical Division
Questions
AI-generated answers, 18 Sep 2026
What is the intended use of the Neodymium: Yag Ophthalmic Laser System 9900?
This system is indicated for ophthalmic laser procedures, specifically excluding posterior capsulotomy and pupillary cutting applications.
Who is the manufacturer of this laser system?
The device is manufactured by the Coherent Medical Division, based in Palo Alto, California.
Is this device FDA authorized?
Yes, the system received FDA PMA authorization on May 9, 1985, under the reference number P830054.