LASERSCAN LSX EXCIMER LASER SYSTEM
FDA premarket approval P980008 · decided 1999-11-12
Approval details
- PMA number
- P980008
- Trade name
- LASERSCAN LSX EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Lasersight Technologies, Inc.
- Date received
- 1998-03-19
- Decision date
- 1999-11-12
- Days to decision
- 603 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Winter Park, FL
- Statement
- Approval for the LaserScan LSX Excimer Laser System. The device is indicated for myopic photorefractive keratectomy: for the reduction or elimination of myopia ranging from -1.0 to less than -6.0 diopters (D) with less than or equal to 1.0 D of astigmatism; in patients with documentation of a stable manifest refraction (+-0.5D) over the prior one year; and in patients who are 18 years of age or older.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS (K001144) | Lasersight Technologies, Inc. | 2000-05-05 |
| ULTRASHAPER KERATOME (K990227) | Lasersight Technologies, Inc. | 2000-01-31 |
| AUTOMATED DISPOSABLE KERATOME (ADK) (K974004) | Lasersight Technologies, Inc. | 1998-01-08 |