Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System
• Generic Name: Excimer laser system
• Applicant: Technolas Perfect Vision GmbH; Messerschmittstr. 1+ 3; München 80992
• PMA Number: P990027
• Supplement Number: S021
• Date Received: 02/02/2023
• Decision Date: 11/22/2023
• Product Code: LZS
• Docket Number: 23M-5212
• Notice Date: 11/27/2023
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

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.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2