Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System
- PMA Number
- P930016
- Supplement Number
- S048
- 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
- June 30, 2017
- Date Received
- December 1, 2016
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 17M-4022
Advisory Committee Statement
Approval for the STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System. The STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System is indicated for Wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: 1) with hyperopia with and without astigmatism as measured by iDesign® Advanced WaveScan Studio System up to +4.00 D spherical equivalent, with up to 2.00 D cylinder;2) with agreement between manifest refraction (adjusted for optical infinity) and iDesign® Advanced WaveScan Studio System refraction as follows: - Spherical Equivalent: Magnitude of the difference is less than 0.625 D. - Cylinder: Magnitude of the difference is less than or equal to 0.5 D;3) 18 years of age or older; and4) with refractive stability (a change of less than or equal to 1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).
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 |