Atlas FDA

TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System

FDA premarket approval P990027/S021 · decided 2023-11-22

Approval details

PMA number
P990027
Supplement
S021
Supplement type
Panel Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System
Generic name
Excimer laser system
Applicant
Technolas Perfect Vision GmbH
Date received
2023-02-02
Decision date
2023-11-22
Days to decision
293 days
Decision code
APPR
Product code
LZS
Advisory committee
Ophthalmic
Expedited review
No
Location
München
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

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510(k) clearances by this applicant

RecordFirmDate
VICTUS Femtosecond Laser Platform (K200724)Technolas Perfect Vision GmbH2020-09-01
VICTUS Femtosecond Laser Platform (K171014)Technolas Perfect Vision GmbH2017-10-19
VICTUS Femtosecond Laser Platform (K151161)Technolas Perfect Vision GmbH2015-06-24
VICTUS FEMTOSECOND LASER PLATFORM (K141379)Technolas Perfect Vision GmbH2015-01-16
VICTUS FEMTOSECOND LASER PLATFORM (K140615)Technolas Perfect Vision GmbH2014-07-15
VICTUS FEMTOSECOND LASER PLATFORM (K132534)Technolas Perfect Vision GmbH2014-02-14
VICTUS FEMTOSECOND LASER PLATFORM (K122386)Technolas Perfect Vision GmbH2013-02-08
VICTUS LASER PLATFORM (K120426)Technolas Perfect Vision GmbH2012-07-31