Neodymium-YAG Ophthalmic Laser OPL-3
PMA P830064
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830064 | Date13 Dec 1984 | 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- Withdrawn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
- Full name
- Neodymium-Yag Op Laser Opl-3
- Generic Name
- Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla
- PMA Number
- FDA Product Code
- LXS
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4392
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S002
Overview
AI-generated summary, 18 Sep 2026
The Neodymium-YAG Ophthalmic Laser OPL-3 is a neodymium:YAG laser designed for posterior capsulotomy and pupillary cutting procedures. It delivers high-energy laser pulses to the eye’s lens capsule or iris, facilitating surgical interventions in ophthalmology without invasive incisions.
This device is supplied as a reusable medical instrument, intended for use in sterile operating environments under direct physician supervision. It operates within Class II regulatory classification under FDA-authorized PMA (P830064) and is approved for ophthalmic applications. Storage and handling must comply with manufacturer guidelines to maintain performance and sterility.