PMA P990027S021

Device: TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System
Applicant: Technolas Perfect Vision GmbH
PMA number: P990027
Supplement: S021
Product code: LZS
Decision date: 2023-11-22
Classification: Ophthalmic
Generic name: Excimer laser system
Approval order 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.

Current openFDA PMA Record#

Device: TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System
Applicant: Technolas Perfect Vision GmbH
PMA number: P990027
Supplement: S021
Product code: LZS
Generic name: Excimer laser system
Decision date: 2023-11-22
Decision code: APPR
Date received: 2023-02-02
Supplement type: Panel Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.