Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)
- PMA Number
- P970053
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- LZS
- Generic Name
- Excimer laser system
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 29, 1999
- Date Received
- February 16, 1999
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 00M-1664
Advisory Committee Statement
Approval for the Nidek EC-5000 Excimer Laser System for Photorefractive Keratectomy for Moderate Myopia with Astigmatism. This device is intended for use in: 1) the reduction or elimination of myopia with astigmatism raning in severity from -1.00 to -8.00 diopters (D), in terms of manifest refraction spherical equivalent (MRSE), with refractive astigmatism ranging in severity from -0.5 to -4.00 D cylinder by manifest refraction; due to cylinder coupling effects on sphere, the lower range of the intended use must be restricted in a step-wise fashion. A nomogram lookup table is provided for specific treatment combinations. 2) patients who have a stable history of both pretreatment myopic astigmatism (i.e., magnitude of change in manifest refraction of <0.5D per year in terms of MRSE for at least one year proceeding treatment) and pretreatment astigmatism (i.e., a magnitude of change of <0.5D per year in cylinder for at least one year preceding treatment); and 3) patients who are over 21 years of age.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZS | Excimer Laser System | FDA class 3 | Unknown |