Product Code: LOI FDA class 3

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

Unknown

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.

510(k)s
1
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active

Basic Information

Product Code
LOI
Device Class
FDA class 3
Medical Specialty
Unknown
Review Panel
OP
Submission Type
2

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K881459 NANOLAS ND:YAG OPHTHALMIC LASER