PMA P930016S010
- Device
- VISX STAR S2 AND S3 EXCIMER LASER SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S010
- Product code
- LZS
- Decision date
- 2000-10-18
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- THESE DEVICES ARE INDICATED FOR PHOTOREFRACTIVE KERATECTOMY (PRK) TREATMENTS: IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.5 D PER YEAR FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; ANDIN PATIENTS 21 YEARS OF AGE OR OLDER FOR THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +0.5 AND + 5.0 D SPHERE AT THE SPECTACLE PLANE WITH REFRACTIVE ASTIGMATISM FROM +0.5 TO +4.0 D WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P930016S010B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- VISX STAR S2 AND S3 EXCIMER LASER SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S010
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2000-10-18
- Decision code
- APPR
- Date received
- 1999-06-18
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- THESE DEVICES ARE INDICATED FOR PHOTOREFRACTIVE KERATECTOMY (PRK) TREATMENTS: IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.5 D PER YEAR FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; ANDIN PATIENTS 21 YEARS OF AGE OR OLDER FOR THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +0.5 AND + 5.0 D SPHERE AT THE SPECTACLE PLANE WITH REFRACTIVE ASTIGMATISM FROM +0.5 TO +4.0 D WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D.