Atlas FDA

TECHNOLAS 217A EXCIMER LASER SYSTEM

FDA premarket approval P990027/S002 · decided 2002-05-17

Approval details

PMA number
P990027
Supplement
S002
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
TECHNOLAS 217A EXCIMER LASER SYSTEM
Generic name
Excimer laser system
Applicant
Technolas Perfect Vision GmbH
Date received
2000-11-24
Decision date
2002-05-17
Days to decision
539 days
Decision code
APPR
Product code
LZS
Advisory committee
Ophthalmic
Expedited review
No
Location
München
Statement
APPROVAL THE TECHNOLAS 217A EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -12.00 D MRSE, WITH SPHERE BETWEEN >-7.00 D TO -10.99 D AND CYLINDER BETWEEN 0.00 AND <-3.00 D; 2) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF THE PRE-OPERAT

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

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