LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)
FDA premarket approval P980008/S005 · decided 2001-09-28
Approval details
- PMA number
- P980008
- Supplement
- S005
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)
- Generic name
- Excimer laser system
- Applicant
- Lasersight Technologies, Inc.
- Date received
- 2000-12-19
- Decision date
- 2001-09-28
- Days to decision
- 283 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Winter Park, FL
- Statement
- APPROVAL FOR THE LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK). THE DEVICE IS INDICATED FOR LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM -0.5 TO LESS THAN -6.0 DIOPTERS (D) SPHERICAL EQUIVALENT, WITH ASTIGMATISM LESS THAN OR EQUAL TO 4.5 D, AS MEASURED AT THE SPECTACLE PLANE; 2) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D, OR <= 10% OF PREOPERATIVE SPHERICAL EQUIVALENT REFRACTION (SER)
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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 |