LADARVISION EXCIMER LASER SYSTEM
FDA premarket approval P970043 · decided 1998-11-02
Approval details
- PMA number
- P970043
- Trade name
- LADARVISION EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories
- Date received
- 1997-09-05
- Decision date
- 1998-11-02
- Days to decision
- 423 days
- Decision code
- APWD
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Indicated for use in photorefractive keratectomy (PRK) treatment for the reduction or elimination of mild to moderate myopia in patients with the following three characteristics: 1) between -1.00D to -10.00D of sphere and less than or equal to -4.00D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50D and -10.00D spherical equivalent (SE) at the spectacle plane where sphere or cylinder is at least 1.00D; 2) who are 21 years of age
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
| Record | Firm | Date |
|---|---|---|
| NEXT GENERATION LASER (K062624) | Alcon Laboratories | 2007-11-05 |
| SMALL VOLUME SYRINGE (K062865) | Alcon Laboratories | 2007-08-23 |
| RGP MULTI-PURPOSE SOLUTION ID 100136 (K000148) | Alcon Laboratories | 2000-04-11 |
| OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP (K984573) | Alcon Laboratories | 1999-09-16 |
| OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K990480) | Alcon Laboratories | 1999-05-10 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K984575) | Alcon Laboratories | 1999-01-14 |
| OPTI-ONE MULTI-PURPOSE SOLUTION (K983973) | Alcon Laboratories | 1998-12-18 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K983780) | Alcon Laboratories | 1998-12-18 |