Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- TECHNOLAS TENEO 317 (MODEL 2) Excimer Laser System
- PMA Number
- P990027
- Supplement Number
- S021
- 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
- November 22, 2023
- Date Received
- February 2, 2023
- Supplement Type
- Panel Track
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
- Docket Number
- 23M-5212
Advisory Committee Statement
Approval for the TECHNOLAS TENEO 317 MODEL 2 Excimer Laser System. This device is indicated for laser-assisted in situ keratomileusis (LASIK) in: Patients for the reduction or elimination of myopic astigmatism up to -10.00 D MRSE, with sphere between -1.00 D to -10.0 D and cylinder between 0.00 and -3.00 D; Patients who are 22 years of age or older; Patients must have a stable refraction in the last 12 months, as documented by previous clinical recordings, i.e., the spherical and cylindrical portions of the manifest distance refraction have not progressed at a rate of more than 0.50 D per year prior to the baseline examination in the eye(s) to be treated.
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 |