Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- EC-5000 EXCIMER LASER SYSTEM
- PMA Number
- P970053
- 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
- December 17, 1998
- Date Received
- November 6, 1997
- Expedited Review
- N
- Docket Number
- 00M-1640
Advisory Committee Statement
Approval for the Nidek EC-5000 Excimer Laser System. This device is indicated for photorefractive keratectomy (PRK) for the reduction or elimination of mild to moderate myopia in patients with the following three characterisitics: 1) In PRK treatments for the reduction or elimination of myopia in the low, moderate, or high ranges (-0.75 Diopters (D) to -13.00D) spherical equivalent (S.E.) at the spectacle plan, uncomplicated by refractive astigmatism (i.e., <0.75D in any meridian). 2) In patients who have a stable history of pretreatment myopia, that is a change of < 0.50D in sphere or cylinder in the 12 months period preceding treatment for correction of myopia <-7.0D S.E., or a change of <1.00D in sphere or cylinder for correction of myopia >-7.0D S.E. 3) In 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 |