WAVELIGHT EX500 LASER SYSTEM
FDA premarket approval P030008/S006 · decided 2011-11-23
Approval details
- PMA number
- P030008
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WAVELIGHT EX500 LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2011-04-04
- Decision date
- 2011-11-23
- Days to decision
- 233 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR INCREASED PULSE FREQUENCY FROM 400 TO 500 HZ, A NEW LASER HEAD, A NEW HOUSING WITH GREATER INTEGRATION OF ACCESSORIES, MODIFIED LASER PULSE TEMPORAL PARAMETERS, NEW EYETRACKER, NEW SCANNER, REMODELED USER INTERFACE, ADDITION OF NETWORKING CAPABILITY, ANDMODIFIED SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME WAVELIGHT EX500 LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR:1) THE REDUCTION OR ELIMINATION OF MYOPIA OF UP TO
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