Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio
- PMA Number
- P930016
- Supplement Number
- S057
- 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 9, 2019
- Date Received
- January 2, 2019
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 19M-4238
Advisory Committee Statement
Approval for the STAR S4 IR® Excimer Laser System and iDESIGN® Refractive Studio. This device is indicated for wavefront-guided photorefractive keratectomy (PRK) in patients:1) with myopia, with or without astigmatism, as measured by iDESIGN® Refractive Studio System with spherical equivalent up to -8.00 D, and cylinder up to -3.00 D. 2) with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® Refractive Studio System refraction as follows: a) Spherical Equivalent: Magnitude of the difference is less than 0.625 D. b) Cylinder: Magnitude of the difference is less than or equal to 0.5 D. 3) in patients 18 years of age or older.4) with refractive stability (a change of </= 1.0 D in manifest refraction spherical equivalent for a minimum of 12 months prior to surgery), and5) with wavefront capture diameter of at least 4 mm.
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 |