LASERSCAN LSX EXCIMER LASER SYSTEM
FDA premarket approval P980008/S008 · decided 2001-10-25
Approval details
- PMA number
- P980008
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LASERSCAN LSX EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Lasersight Technologies, Inc.
- Date received
- 2001-10-05
- Decision date
- 2001-10-25
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Winter Park, FL
- Statement
- APPROVAL TO INCREASE THE PULSE RATE OF THE LASER FROM 100 TO 200 HZ.
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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 |