Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
Laser, Neodymium:YAG, Ophthalmic for Uses Other Than Posterior Capsulotomy and Cutting Pupillary Membrane is an Nd:YAG ophthalmic laser used in eye surgery for applications beyond the established indications of posterior lens capsulotomy and pupillary membrane cutting, such as treatment of glaucoma, vitreous strands, or other anterior and posterior segment conditions. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LOI; no regulation number has been assigned, and the review panel is Ophthalmology. No special flags apply to this device.
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Basic Information
- Product Code
- LOI
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OP
- Submission Type
- 2
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881459 | NANOLAS ND:YAG OPHTHALMIC LASER | Apr 13, 1988 | Substantially Equivalent | Biophysic Medical, Inc. |