PMA P030008S004
- Device
- WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P030008
- Supplement
- S004
- Product code
- LZS
- Decision date
- 2006-04-19
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR THE WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM. THE DEVICE USED OPTICAL ZONES OF 6.0-7.0 MM WITH AN ABLATION/TREATMENT ZONE UP TO 9.0 MM, 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; 2) PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030008S004B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P030008
- Supplement
- S004
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2006-04-19
- Decision code
- APPR
- Date received
- 2005-10-24
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM. THE DEVICE USED OPTICAL ZONES OF 6.0-7.0 MM WITH AN ABLATION/TREATMENT ZONE UP TO 9.0 MM, 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; 2) PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS