WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
FDA premarket approval P030008/S005 · decided 2007-04-09
Approval details
- PMA number
- P030008
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2006-12-19
- Decision date
- 2007-04-09
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A CHANGE IN THE REPETITION RATE FROM 200 HZ TO 400 HZ. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM OF UP TO 6.00 DIOPTERS (D) AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE
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